Label: LACTIC ACID- lactic acid cream
- NDC Code(s): 58980-915-40
- Packager: Stratus Pharamceuticals, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- SPL UNCLASSIFIED SECTION
For dry itchy skin and minor skin irritation
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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.Close
Not for use in patients know to be sensitive to the active or inactive ingredients in Lactic Acid 10% E Cream.Close
Minimize or avoid sun exposure to areas of the skin treated with Lactic Acid 10% E Cream.Close
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.Close
- 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.Close
- HOW SUPPLIED
4oz (113.4g) net wt. polypropylene jar NDC NDC 58980-915-40
Store at controlled room temperature 15° - 30°C (59° - 86°F). See bottom of jar for lot number and expiration date.
- SPL UNCLASSIFIED SECTION
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6727
- PRINCIPAL DISPLAY PANEL - 113.4g Label
10% E CREAM
For dry, itchy skin
and minor skin irritation
For Topical Use Only
Net WT. 4.0 oz. (113.4g)
- INGREDIENTS AND APPEARANCE
lactic acid cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-915 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lactic Acid (UNII: 33X04XA5AT) (Lactic Acid - UNII:33X04XA5AT) Lactic Acid 11.34 g in 113.4 g Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-915-40 113.4 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved other 01/16/2009 Labeler - Stratus Pharamceuticals, Inc (789001641) Establishment Name Address ID/FEI Business Operations Sonar Products, Inc 104283945 MANUFACTURE