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Name:Lactic Acid
Manufacturer:Stratus Pharamceuticals, Inc
Category:Prescription Marketed Drugs


LACTIC ACID 10% LOTION

LACTIC ACID - lactic acid lotion 
Stratus Pharamceuticals, Inc

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.

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LACTIC ACID 10% LOTION

For dry itchy skin and minor skin irritation

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Rx only

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.

INGREDENTS

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

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.

CONTRAINDICATION

Not for use in patients know to be sensitive to the active or inactive ingredients in Lactic Acid 10% Lotion.

WARNINGS

Minimize or avoid sun exposure to areas of the skin treated with Lactic Acid 10% Lotion.

PRECAUTIONS

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.

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 SUPPLIED

12 oz. (354.84ml) net wt. high density polyethylene bottle NDC 58980-918-95

STORAGE

Store at controlled room temperature 15° - 30°C (59° - 86°F). See bottom of bottle for lot number and expiration date.

Distributed by
STRATUS

PHARMACEUTICALS INC

Manufactured for
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6727

Customer Service
Telephone: 1-800-442-7882
Fax: 305-254-6875

JG LAL02008-1210

PRINCIPAL DISPLAY PANEL - 354.84 mL Label

NDC 58980-918-95

Rx only

LACTIC ACID
10% LOTION

For dry, itchy skin and
minor skin irritation

For Topical Use Only

STRATUS
PHARMACEUTICALS INC

Net WT. 12.0 fl. oz. (354.84 mL)

Principal Display Panel - 354.84 mL Label

LACTIC ACID 
lactic acid lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-918
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lactic Acid (Lactic Acid) Lactic Acid 35.484 mL  in 354.84 mL
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58980-918-95 354.84 mL in 1 BOTTLE, PUMP None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 01/08/2009

Labeler - Stratus Pharamceuticals, Inc (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE

Revised: 10/2009 Stratus Pharamceuticals, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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