RENOVA (tretinoin cream) 0.05% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9- (2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below.

Tretinoin is available as RENOVA at a concentration of 0.05% w/w in a water-in-oil emulsion formulation consisting of butylated hydroxytoluene, citric acid monohydrate, dimethicone 50 cs, edetate disodium, fragrance, hydroxyoctacosanyl hydroxystearate, light mineral oil, methoxy PEG-22/dodecyl glycol copolymer, methylparaben, PEG-45/dodecyl glycol copolymer, purified water, quaternium-15, stearoxytrimethylsilane and stearyl alcohol, and sorbitol solution.

Last updated on RxList: 12/10/2008

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

RENOVA (tretinoin cream) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs (see bullet point 3 for populations in which effectiveness has not been established). RENOVA DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams.

• RENOVA 0.05% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
• RENOVA should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sunlight avoidance program alone.
• The effectiveness of RENOVA 0.05% in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of RENOVA 0.05%. Thus the effectiveness and safety of RENOVA 0.05% in these populations are not known at this time.
• Neither the safety nor the effectiveness of RENOVA for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
• Neither the safety nor the efficacy of using RENOVA 0.05% daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (See WARNINGS section.)

• Do NOT use RENOVA if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy,
• Do NOT use RENOVA if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face,
• Do NOT use RENOVA if the patient is inherently sensitive to sunlight,
• Do NOT use RENOVA if the patient is also taking drug(s) known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

RENOVA should be applied to the face once a day in the evening, using only enough to cover the entire affected area lightly. Patients should gently wash their face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying RENOVA. The patient should apply a pea-sized amount of cream to cover the entire affected face lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of RENOVA may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with RENOVA 0.05% is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of RENOVA 0.05% therapy, a majority of patients will lose most mitigating effects of RENOVA 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using RENOVA 0.05% daily for greater than 48 weeks have not been established.

Application of larger amounts of medication than recommended may not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with RENOVA may use cosmetics but the areas to be treated should be cleansed before the medication is applied. (See PRECAUTIONS section.)

RENOVA is available in these sizes:

NDC 0062-0185-0020 gram tube
NDC 0062-0185-0540 gram tube
NDA 0062-0185-0360 gram tube

Storage: Store at 25°C (77°F), excursions permitted to 15-30°C (59°F-86°F). DO NOT FREEZE.

QUESTIONS: Physicians and Pharmacists can call 1-800-462-7762, from 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday.

ORTHO DERMATOLOGICAL DIVISION, A division of ORTHO-McNEIL PHARMACEUTICAL CORPORATION, Raritan, New Jersey 08869. Revised July 2000. FDA rev date: 3/20/2001

Last updated on RxList: 12/10/2008

(See WARNINGS and PRECAUTIONS sections.)

In double-blind, vehicle-controlled studies involving 179 patients who applied RENOVA 0.05% to their face, adverse reactions associated with the use of RENOVA 0.05% were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of RENOVA 0.05% because of adverse reactions. These discontinuations were due to skin irritation or related cutaneous adverse reactions.

Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy with RENOVA 0.05%. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. In most patients the dryness, peeling, and redness recurred after an initial (24 week) decline.

In spontaneous post-marketing adverse event reporting for RENOVA 0.05%, approximately 2% of those were for skin hypo- or hyperpigmentation. Other spontaneously reported adverse events predominantly appear to be local reactions similar to those seen in clinical trials.

Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with RENOVA because they may increase irritation with RENOVA.

RENOVA should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

Last updated on RxList: 12/10/2008

• RENOVA is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic use with RENOVA are not known. There is evidence of atypical changes in melanocytes and keratinocytes, and of increased dermal elastosis in some patients treated with RENOVA for longer than 48 weeks. The significance of these findings is unknown.
• Safety and effectiveness of RENOVA 0.05% in individuals with moderately or heavily pigmented skin have not been established.
• RENOVA should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

Exposure to sunlight (including sunlamps) should be avoided or minimized during use of RENOVA because of heightened sunburn susceptibility. Patients should be warned to use sunscreens (minimum SPF of 15) and protective clothing when using RENOVA. Patients with sunburn should be advised not to use RENOVA until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using RENOVA and follow the precautions outlined in the Patient Package Insert.

RENOVA should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether, and consider additional appropriate therapy.

Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with caution in patients with this condition.

Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

General

RENOVA should be used only as an adjunct to a comprehensive skin care and sunlight avoidance program. (See INDICATIONS AND USAGE section.)

If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use of RENOVA should be discontinued.

Weather extremes, such as wind or cold, may be more irritating to patients using tretinoin containing products.

Information for Patients

RENOVA 0.05% is to be used as described below unless otherwise directed by your physician:

1. It is for use on the face only.
2. Avoid contact with the eyes, ears, nostrils, angles of the nose, and mouth. RENOVA may cause severe redness, itching, burning, stinging, and peeling if used on these areas.
3. In the evening, gently wash your face with a mild soap. Pat skin dry and wait 20-30 minutes before applying RENOVA. Apply only a pea-sized amount of RENOVA to your face at one time. This should be enough to cover the entire affected area lightly.
4. Do not wash your face for at least one hour after applying RENOVA.
5. For best results, you are advised not to apply another skin care product or cosmetic for at least one hour after applying RENOVA.
6. In the morning, apply a moisturizing sunscreen, SPF 15 or greater.
7. RENOVA is a serious medication. Do not use RENOVA if you are pregnant or attempting to become pregnant. If you become pregnant while taking RENOVA, please contact your physician immediately.
8. Avoid sunlight and other medicines that may increase your sensitivity to sunlight.
9. RENOVA does not remove wrinkles or repair sun-damaged skin.

Please refer to the Patient Package Insert for additional patient information.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas were observed in some female mice. These concentrations are lower than the concentration of tretinoin in the clinical formulation (0.05%). A dose related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day. These doses are 4 and 8 times the maximum human systemic dose, when adjusted for total body surface area. The biological significance of the neoplastic findings is not clear because they occurred at doses that exceeded the maximally tolerated dermal dose of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (1/5^th of the maximum human systemic dose, adjusted for total body surface area). For purposes of comparisons of the systemic animal exposure to the systemic human exposure, the maximum human systemic dose is 1 gram of 0.05% RENOVA applied daily to a 50 kg person (0.01 mg tretinoin/kg body weight, or 0.37 mg/m²total body surface area).

Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies in humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.

The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative.

In dermal Segment I fertility studies in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0. 5 mg/kg/day (8 times the maximum human systemic dose adjusted for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (4 times the maximum human systemic dose adjusted for total body surface area) and above were observed. A dermal Segment III study with RENOVA has not been performed in any species. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day ( > 33 times the maximum human systemic dose adjusted for total body surface area).

Pregnancy

Teratogenic effects: Pregnancy Category C.

ORAL tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. It was teratogenic and fetotoxic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (17 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which, metabolically, is closer to humans for tretinoin than the other species examined, fetal malformations were reported at doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (167 times the maximum human systemic dose adjusted for total body surface area), although increased skeletal variations were observed at all doses. A dose-related increase in embryolethality and abortion was reported. Similar results have also been reported in pigtail macaques.

TOPICAL tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (17 times the maximum human systemic dose adjusted for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was dermally applied.

There are other reports in New Zealand White rabbits administered doses of greater than 0.2 mg/kg/day (7 times the maximum human systemic dose adjusted for total body surface area) of an increased incidence of domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species.

In contrast, several well-controlled animal studies have shown that dermally applied tretinoin may be fetotoxic, but not overtly teratogenic, in rats and rabbits at doses of 1.0 and 0.5 mg/kg/day, respectively (17 times the maximum human systemic dose adjusted for total body surface area in both species).

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally-associated congenital malformations have been reported during twenty-five years of clinical use of another formulation of topical tretinoin (Retin-A). Although no definite pattern of teratogenicity and no causal association has been established from these cases, 5 of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.

Non-teratogenic effects

Dermal tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (17 times the human topical dose normalized for total body surface area). Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death, in rats when administered 2.5 mg/kg/day (42 times the maximum human systemic dose adjusted for total body surface area).

There are, however, no adequate and well-controlled studies in pregnant women. RENOVA should not be used during pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness on the face with RENOVA may be postponed in nursing mothers until after completion of the nursing period.

Pediatric Use

Safety and effectiveness in patients less than 18 years of age have not been established.

Geriatric Use

Clinical studies of RENOVA 0.05% did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

Last updated on RxList: 12/10/2008

Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

Last updated on RxList: 12/10/2008

Tretinoin is an endogenous retinoid metabolite of Vitamin A that binds to intracellular receptors in the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of a tretinoin containing topical drug product. Although tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, other mechanisms such as irritation, or both.

The effect of tretinoin on skin with chronic photodamage has not been evaluated in animal studies. When hairless albino mice were treated topically with tretinoin shortly after a period of UVB irradiation, new collagen formation was demonstrated only in photodamaged skin. However, in human skin treated topically, adequate data have not been provided to demonstrate any increase in desmosine, hydroxyproline, or elastin mRNA. Application of 0.1% tretinoin cream to photodamaged human forearm skin was associated with an increase in antibody-staining for procollagen I propeptide. No correlation was made between procollagen I propeptide staining with collagen I levels or with observed clinical effects. Thus, the relationships between the increased collagen in rodents, increased procollagen I propeptide in humans, and the clinical effects of tretinoin have not yet been clearly defined.

Tretinoin was shown to enhance UV stimulated melanogenesis in pigmented mice. Generalized amyloid deposition in the basal layer of tretinoin treated skin was noted in a two year mouse study. In a different study, hyalinization at tretinoin treated skin sites was noted at doses beginning at 0.25 mg/kg in CD-1 mice.

The transdermal absorption of tretinoin from various topical formulations ranged from 1% to 31% of applied dose, depending on whether it was applied to healthy skin or dermatitic skin. When percutaneous absorption of RENOVA 0.05% was assessed in healthy male subjects (n=14) after a single application, as well as after repeated daily applications for 28 days, the absorption of tretinoin was less than 2% and endogenous concentrations of tretinoin and its major metabolites were unaltered.

Clinical Trials

Two adequate and well-controlled trials were conducted involving a total of 161 evaluable patients (under 50 years of age) treated with RENOVA 0.05% and 154 evaluable patients treated with the vehicle cream on the face for 24 weeks as an adjunct to a comprehensive skin care and sun avoidance program, to assess the effects on fine wrinkling, mottled hyperpigmentation, and tactile skin roughness. Patients were evaluated at baseline on a 10 point scale and changes from that baseline rating were categorized as follows:

No Improvement: No change or an increase of 1 unit or more.
Minimal Improvement: Reduction of 1 unit.
Moderate Improvement: Reduction of 2 units or more.

In these trials, the fine wrinkles, mottled hyperpigmentation, and tactile roughness of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure.

The results of these assessments are as follows:

Most of the improvement in these signs was noted during the first 24 weeks of therapy. Thereafter, therapy primarily maintained the improvement realized during the first 24 weeks.

A majority of patients will lose most mitigating effects of RENOVA 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin with discontinuation of a comprehensive skin care and sun avoidance program including RENOVA 0.05%; however, the safety and effectiveness of using RENOVA 0.05% daily for greater than 48 weeks have not been established.

Last updated on RxList: 12/10/2008

RENOVA®
(reh-NO-vah)
Generic Name: Tretinoin Cream (0.05%)

Use only on the Face

Read this leaflet carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This leaflet does not take the place of talks with your doctor. It is important for you to talk with your doctor about how to use RENOVA for the best results and how to reduce side effects.

What is the Most Important Information about RENOVA?

RENOVA is a serious medicine. Do not use RENOVA if you are pregnant or attempting to become pregnant. If you become pregnant while taking RENOVA, please contact your doctor immediately.

Avoid sunlight and other medicines that may increase your sensitivity to sunlight (See “Who should not use RENOVA?”).

RENOVA does not remove wrinkles or repair sun-damaged skin. (See “What is RENOVA?” for more details.) RENOVA 0.05% has not been tested in people over age 50 or in people with medium or dark skin color. (See “Who should not use RENOVA?”)

What is RENOVA 0.05%?

RENOVA 0.05% is a prescription medicine that may reduce fine facial wrinkles, facial mottled hyperpigmentation, and facial skin roughness. It is for patients who are also using a skin care and sunlight avoidance program. RENOVA does not remove wrinkles or repair sun-damaged skin. RENOVA does not work for everyone who uses it. It may work better for some patients than for others.

RENOVA should be used only under the guidance of your doctor as part of a skin care and sunlight avoidance program. This program should include avoiding sunlight as much as possible, using clothing to protect you from sunlight, using sunscreens with a minimum SPF of 15, and using face creams that add moisture to the skin.

When you use RENOVA, you will not see improvement right away. Generally, you may notice some effects in 3 to 4 months. If RENOVA treatment is stopped, the improvement may gradually disappear.

The use of RENOVA 0.05% in patients for more than 48 weeks has not been studied. Therefore, it is not known if RENOVA 0.05% is safe or works if used longer than 48 weeks. RENOVA 0.05% has not been shown to work or to be safe in people over age 50, in people with medium to dark skin color, in people with visible actinic keratosis, or in people with a history of skin cancer.

Who should not use RENOVA?

Do not use RENOVA if:

• you are pregnant or plan to become pregnant. If you become pregnant while taking RENOVA, please contact your doctor immediately.
• you are sunburned or your skin is irritated
• you are highly sensitive to sunlight
• you are allergic to any of RENOVA's ingredients. The active ingredient is tretinoin. Ask your doctor or pharmacist about the inactive ingredients.

RENOVA can cause increased skin irritation and increased chance of sunburn.

Tell your doctor if you have any skin condition. RENOVA may not be right for you.

Because RENOVA may make your skin more likely to burn from sunlight, tell your doctor if you are using other medicines that increase sensitivity to sunlight. You should not use RENOVA with such medicines. These include, but are not limited to:

• thiazides (to treat high blood pressure)
• tetracyclines, fluoroquinolones, sulfonamides (to treat infection)
• phenothiazines (to treat serious emotional problems)

If you are taking any prescription or non-prescription medicines, check with your doctor to make sure you can use RENOVA with them.

We do not know if RENOVA is passed to infants through breast milk. Therefore, tell your doctor if you are breast feeding.

How should I use RENOVA?

Use RENOVA as part of a total skin care and sunlight avoidance program. Follow your doctor's instructions on how to use RENOVA. RENOVA is usually applied to the face once a day in the evening, following the 3 steps listed below:

• Gently wash your face with a mild soap.
• Pat the skin dry and wait 20-30 minutes before applying RENOVA.
• Apply only a pea-sized amount of RENOVA to the face at one time. It should be enough to cover the entire affected area lightly.

Be especially careful when applying RENOVA to avoid your eyes, ears, nostrils, angles of the nose, and mouth. RENOVA may cause severe redness, itching, burning, stinging, and peeling if used on these areas.

Using too much RENOVA may increase discomfort and skin redness and peeling.

You may use cosmetics one hour after applying RENOVA. If you do, be sure to clean your face well before applying RENOVA again. Skin moisturizers should be used at least every morning to protect the treated areas from dryness.

Use sunscreen and wear protective clothing to protect the treated areas from sunlight. If you sunburn easily, or if you spend a lot of time exposed to sunlight, be especially careful to protect your skin.

What should I avoid while using RENOVA?

RENOVA can make your treated skin more sensitive to sunlight. Therefore, keep out of the sunlight as much as possible and do not use sunlamps. Avoid as much as possible products that can increase skin irritation, such as:

• other skin medicines
• medicated or abrasive (rough) soaps
• permanent wave solutions
• chemical hair removers or waxes
• electrolysis
• products with alcohol, spices, astringents, or lime
• cleansers, shampoos, or cosmetics with a strong drying effect
• other products that may irritate your skin

What are the possible side effects of RENOVA?

You may feel brief warmth or stinging on your skin after you use RENOVA. Most patients report peeling, dry skin, burning, stinging, itching, and redness,. These are usually mild to moderate and occur early in treatment. Contact your doctor if the side effects are a problem.

General advice about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Only use RENOVA to treat the condition that your doctor has prescribed it for. Do not give RENOVA to other people. It may harm them.

This leaflet summarizes the most important information about RENOVA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about RENOVA that is written for health professionals.

Last updated on RxList: 12/10/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

TRETINOIN CREAM - TOPICAL

(tret-ih-NO-in)

COMMON BRAND NAME(S): Renova

USES: This medication is used to improve the appearance of the skin by reducing fine lines and wrinkles, reducing roughness, and improving skin color. It should be used with a skin care and sunlight-avoidance program that includes moisturizer and daily use of an effective sunscreen (minimum SPF 15).

Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells. Tretinoin does not repair sun-damaged skin or reverse aging due to sun exposure.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Your doctor may use this medication to treat other skin conditions, including acne.

HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Ask your doctor or pharmacist if you have any questions.

Gently clean your face with a mild or soapless cleanser and pat skin dry. Wait 20-30 minutes before applying this medication. Apply a pea-sized amount of cream, using just enough to cover your entire face lightly, usually once a day before bedtime or as directed by your doctor. Be careful to avoid your eyes, nostrils and mouth. Do not wash your face or apply another skin care product for at least 1 hour after using this product.

Do not use more of this medication than prescribed or use in larger amounts. It will not give you faster or better results, but will increase the risk of developing redness, peeling and pain. Do not use on cut, scraped, sunburned, or eczema-affected skin.

Avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.

Effects of this medication will appear slowly, with most improvement seen in the first 6 months of use.

If used for acne, your condition may worsen at first, then improve.

SIDE EFFECTS: A brief sensation of warmth or stinging may occur immediately after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2-4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes).

If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Your doctor may want you to decrease how often you use tretinoin, change the strength, or have you stop using it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Notify your doctor if you experience: blistering, crusting, severe burning/swelling of the skin, eye redness and watering (conjunctivitis), eyelid swelling, darkening or lightening of skin color.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using tretinoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use a sunscreen daily, and wear protective clothing when outdoors. Wait until your skin has completely recovered from a sunburn before using tretinoin.

Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product.

If you have recently used products containing sulfur, resorcinol or salicylic acid, use tretinoin with caution. Wait until the effects of such products on the skin have decreased before using tretinoin.

This medication is not recommended for use during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Precautions section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: products containing alpha hydroxy acid, products containing glycolic acid.

If you are currently using medications containing the ingredients listed above, tell your doctor or pharmacist before starting tretinoin.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotions), medicated or abrasive soaps and cleansers, products containing sulfur, resorcinol or salicylic acid, soaps and cosmetics with a strong drying effect, other drugs that may increase your sensitivity to sunlight (e.g., fluoroquinolones such as ciprofloxacin, tetracyclines, thiazide water pills such as hydrochlorothiazide, sulfa drugs such as sulfamethoxazole, phenothiazines such as chlorpromazine).

Benzoyl peroxide should not be applied at the same time as this medication.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed. Symptoms of overdose may include excessive redness, peeling, and discomfort.

NOTES: Cosmetics may be used 1 hour after applying tretinoin. Be sure to clean skin well before applying the medication. Daily moisturizer should be used to protect your skin from dryness.

Do not share this medication with others.

MISSED DOSE: If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage at 59-86 degrees F (15-30 degrees C) is permitted. Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.