Lactic Acid Lotion
Generic Name: lactic acid
Dosage Form: topical lotion
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
LACTIC ACID 10% LOTION
For dry itchy skin and minor skin irritation
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Lactic Acid Lotion Description
Lactic Acid, an alpha-hydroxy acid, is a natural skin-moisturizing agent. It has beneficial effects on dry skin (xerosis) and in severe discomfort of hyperkeratotic conditions.
Active Ingredient: Lactic Acid 10%, Inactive Ingredients: Purified Water, Isopropyl Palmitate, Cetyl Alcohol, Gylceryl Stearate and PEG 100 Stearate, PEG-40 Stearate, Caprylic/Caprylic Triglyceride, Lecithin, Dimethicone, Glycerin, Methylparaben, Propylparben, Disodium EDTA, Imidurea and Sodium Benzoate.
Indications and Usage for Lactic Acid Lotion
Lactic Acid 10% Lotion is a white rich moisturizer for dry skin (xerosis) and is indicated to moisturize and soften dry, itchy skin and minor skin irritation.
Not for use in patients know to be sensitive to the active or inactive ingredients in Lactic Acid 10% Lotion.
Minimize or avoid sun exposure to areas of the skin treated with Lactic Acid 10% Lotion.
FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN. Do not use in or near eyes, lips or mucous membranes. Patient may experience mild stinging or burning and peeling may occur on sensitive or irritated skin areas. If sensitivity or irritation occurs, immediately discontinue use and consult a medical professional. Caution is advised when used on the face due to the potential for irritation. The potential for post-inflammatory hypo-hyperpigmentation has not been studied.
Avoid administering Lactic Acid 10% Lotion to pregnant women unless clearly required and use caution in its use for nursing mothers. Safety and effectiveness in pediatric patients have not been established.
Lactic Acid Lotion Dosage and Administration
Apply thoroughly twice daily on affected areas or as prescribed by a Physician. Dispense in accordance with applicable state law. This product has not been approved by the FDA, is not listed in the Orange Book, and has not been approved or rated for therapeutic equivalence with any other product.
How is Lactic Acid Lotion Supplied
12 oz. (354.84ml) net wt. high density polyethylene bottle NDC 58980-918-95
Store at controlled room temperature 15° - 30°C (59° - 86°F). See bottom of bottle for lot number and expiration date.
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6727
PRINCIPAL DISPLAY PANEL - 354.84 mL Label
For dry, itchy skin and
minor skin irritation
For Topical Use Only
Net WT. 12.0 fl. oz. (354.84 mL)
Lactic Acid Lotion
|Labeler - Stratus Pharamceuticals, Inc (789001641)|
|Sonar Products, Inc||104283945||MANUFACTURE|