Lac-Hydrin specially formulates 12% lactic acid, neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5-5.5. Lac-Hydrin (ammonium lactate) Lotion, 12% also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methyl- and propylparabens, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

Last updated on RxList: 12/17/2007

Lac-Hydrin is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

Lac-Hydrin® (ammonium lactate) Lotion, 12% is available in a 225g (NDC 0072-5712-08) plastic bottle and a 400g (NDC 0072-5712-14) plastic bottle.

Store at controlled room temperature 15°C-30°C (59°F-86°F).

Manufactured for: Bristol-Myers Squibb Co. Princeton, NJ 08543 USA. by: Contract Pharmaceuticals Limited Niagara Buffalo, NY 14213 USA. FDA revision date: 11/9/2007

Last updated on RxList: 12/17/2007

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation.

Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

No information provided.

Last updated on RxList: 12/17/2007

Sun exposure to areas of the skin treated with Lac-Hydrin (ammonium lactate) Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Lac-Hydrin Lotion should be discontinued if hypersensitivity is observed.

General

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions or that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of ammonium lactate formulations was evaluated in the Ames assay and in the mousein vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with ammonium lactate formulations there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m²/day), approximately 0.4 times the human topical dose.

Pregnancy

Teratogenic Effects: Pregnancy Category B

Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m²/day in the rat and 7200 mg/m²/day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lac-Hydrin Lotion should be used during pregnancy only if clearly needed.

Nursing Mothers

Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lac-Hydrin is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Lac-Hydrin have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use

Clinical studies of Lac-Hydrin (ammonium lactate) Lotion, 12% did not include sufficient numbers 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. In general, dose selection for an elderly patient should be cautious.

Last updated on RxList: 12/17/2007

The oral administration of Lac-Hydrin to rats and mice showed this drug to be practically non-toxic ^(LD50^>15 mL/kg).

Lac-Hydrin Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Last updated on RxList: 12/17/2007

Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known.

An in vitro study of percutaneous absorption of Lac-Hydrin Lotion using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

Last updated on RxList: 12/17/2007

Patients using Lac-Hydrin (ammonium lactate) Lotion, 12% should receive the following information and instructions:

1. This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
2. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
3. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
4. If the skin condition worsens with treatment, the medication should be promptly discontinued.

Last updated on RxList: 12/17/2007

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.

AMMONIUM LACTATE 12% - TOPICAL

(a-MOE-nee-um LAK-tate)

COMMON BRAND NAME(S): Hydrolac, Lac-Hydrin

USES: This medication is used to treat dry, scaly skin conditions (e.g., xerosis, ichthyosis vulgaris) and can also help relieve itching from these conditions. This medication works by increasing the moisture in the skin.

HOW TO USE: If you are using the lotion, shake the bottle well before using.

Apply a thin layer of this medication to the affected areas of the skin, usually twice daily or as directed by your doctor. Rub the medication thoroughly into the skin.

Be careful to avoid your eyes, lips, inside your mouth/nose, the vaginal area, and any areas of broken skin. Stinging or burning may occur when this medication is applied on the face, on chapped skin, or on a recently shaved area of the skin. Consult your doctor or pharmacist for more details.

Inform your doctor if your skin condition does not improve or worsens.

SIDE EFFECTS: Stinging, burning, and redness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: darkening/lightening of the skin, small red dots on 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 ammonium lactate, 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: wounds or sores on the skin.

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

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

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

DRUG INTERACTIONS: 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.

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

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: This medication may be harmful if swallowed. If swallowing/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.

NOTES: Do not share this medication with others.

Some ways to help prevent dry skin include using lukewarm (not hot) water when bathing, taking baths/showers less often (e.g., every 1-2 days), keeping baths/showers short, and using a humidifier when the air is very dry.

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. Refer to storage information printed on your package for the exact temperature range. 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.