Each mL of MELQUIN-3 TOPICAL SOLUTION Contains:

ACTIVE: Hydroquinone 3% (30mg)
INACTIVES: SD Alcohol 40B (45% by volume), Purified Water, Isopropyl Alcohol (4% by volume), Propylene Glycol, Laureth-4 Hydroxyethyl Cellulose and Ascorbic Acid.

Hydroquinone is 1, 4-Benzenediol, with a chemical formula of C₆H₆O₂ and a molecular weight of 110.11.

Caution: FOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC, NASAL. OR OTIC USE.

Last updated on RxList: 1/20/2009

ALPHAQUIN HP 4% CREAMNUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION are indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other undesired areas of melanin hyperpigmentation.

NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. MELPAQUE HP 4% CREAM should be applied to affected areas twice daily, in the morning and before bedtime, or as directed by a physician. Do not rub MELPAQUE HP 4% CREAM in. During the day, an effective broad spectrum sunscreen should be used with MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION. Unnecessary solar exposure should be avoided. There is no recommended dosage for children under 12 years of age except under the advice and supervision of a physician. Keep container tightly closed. NOTE: Slight darkening of NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION is normal and does not affect potency of the product.

MELQUIN-3 TOPICAL CREAM (Hydroquinone 3%) is supplied as follows:

SIZE	NDC NUMBER
1 FLUID OUNCE (29.57 ML.)	58980-0476-10

Stratus Pharmaceuticals Inc. FDA rev date: n/a

Last updated on RxList: 1/20/2009

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.

No information provided.

Last updated on RxList: 1/20/2009

1. Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
2. To evaluate possible susceptibility to irritation or sensitivity, each patient should begin by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation, or vesicle formation occurs. Use of ALPHAQUIN HP 4%, CREAM, NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION in paranasal and infraorbital areas increases the chance of irritations (See ADVERSE REACTIONS). If no improvement is seen after two months of treatment, use of this product should be discontinued.
3. Sunscreen use is an essential aspect of hydroquinone therapy since even minimal sunlight exposure stimulates melanocyte activity. The sunscreens in ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM and NUQUIN HP 4% GEL and the sunblocks in MELPAQUE HP 4% CREAM provide the necessary sun protection during skin bleaching activity. During the depigmentation maintenance treatment subsequent to the intensive depigmentation therapy, sun exposure of the bleached skin should be avoided to prevent repigmentation.
4. There are no sunblocking or sunscreen agents in MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION. Sun exposure should be minimized by using a sunscreen agent, or protective clothing to cover bleached skin in order to prevent repigmentation from occurring. For daytime treatment use ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL or MELPAQUE HP 4% CREAM.
5. NUQUIN HP 4% GEL contains Sodium Bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
6. ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, MELPAQUE HP 4% CREAM and MELQUIN HP 4% CREAM contains Sodium Metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
7. Keep this and all other medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.
8. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and antiseptic effect may occur if applied to the lips.

(See WARNINGS)

Pregnancy Category C

Animal reproduction studies have not been conducted with hydroquinone. It is also not known whether hydroquinone can cause fetal harm when administered on a pregnant women or can affect reproductive capacity. It is also not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated.

Nursing Mothers

It is not known whether topical administration of hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by nursing mother.

Pediatric Use

Safety and effectiveness in children below the age of 12 years have not been established.

Last updated on RxList: 1/20/2009

There have been no systemic reactions reported from the used of topical hydroquinone treatment. However, treatment should be limited to relatively small areas of the body at one time since some patients may experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

ALPHAQUIN HP 4% CREAM, NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL, MELPAQUE HP 4% CREAM, MELQUIN HP 4% CREAM and MELQUIN-3 TOPICAL SOLUTION are contraindicated in persons who have shown hypersensitivity to hydroquinone or any of the other ingredients. The safety of topical treatment of hydroquinone during pregnancy or in children (12 years and under) has not been established. (See PRECAUTIONS).

Last updated on RxList: 1/20/2009

Topical application of hydroquinones produce a reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) [Denton, C., et al, 1952 (1)] and supression of other melanocyte metabolic processes [Jimbow, K., et al, 1974 (2)]. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas [Parrish, J., et al, 1978 (3)].

Last updated on RxList: 1/20/2009

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 1/20/2009

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.

HYDROQUINONE - TOPICAL

(hi-dro-KWIN-own)

COMMON BRAND NAME(S): Eldoquin, Epiquin Micro, Lustra, Melanex

USES: Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin.

This medicine works by blocking the process in the skin that leads to discoloration.

HOW TO USE: Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin.

Apply this medication to the affected areas of skin, usually twice daily or as directed by your doctor. This medication is for use on the skin only. If it is used incorrectly, unwanted skin lightening may occur. Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water.

This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing on the treated areas of skin when outdoors.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Inform your doctor if your condition persists or worsens after 2 months.

SIDE EFFECTS: See also How to Use.

Mild burning, stinging, redness, and dryness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that 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.

Stop using hydroquinone and tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, skin cracking, blue-black darkening of the skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to sulfites; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, other skin conditions (e.g., eczema, psoriasis).

During pregnancy, this medication should be used only when clearly needed. 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: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or 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. Canada residents can call a provincial poison control center. Symptoms after swallowing may include: shaking (tremors), seizures.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Different forms of this product have different storage temperatures. Consult your pharmacist or the product labeling for more information. Do not store in the bathroom. 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.