LACTIC ACID cream
[Stratus Pharamceuticals, Inc]
|Category||DEA Schedule||Marketing Status|
|HUMAN PRESCRIPTION DRUG LABEL||unapproved drug other|
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, Vitamin E 3500IU/ OZ, Isopropyl Palmitate, Cetyl Alcohol, Glyceryl Stearate and PEG 100 Stearate, PEG-40 Stearate, Caprylic/ Capric Triglyceride, Lecithin, Dimethicone, Glycerin. Methylparaben Propylparaben, Disodium EDTA, Imidurea, Sodium Benzoate.
INDICATIONS AND USAGE
Lactic Acid 10% E Cream 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% E Cream.
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% E Cream 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.
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.
4oz (113.4g) net wt. polypropylene jar NDC NDC 58980-915-40
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6727
lactic acid cream
|Labeler - Stratus Pharamceuticals, Inc (789001641)|
|Sonar Products, Inc||104283945||MANUFACTURE|