LACTIC ACID  - lactic acid cream 
River's Edge Pharmaceuticals, LLC

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10% LACTIC ACID CREME

10% LACTIC ACID CREME

Relief of Dry, Scaly, Itching Skin

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx Only

Lactic Acid has been reported as an effective naturally occurring humectant in the skin. It has beneficial effects on dry skin and in severe discomfort of hyperkeratotic conditions. Vitamin E has been used as an aid to control dry or chapped skin, and for the relief of and discomfort from minor skin disorders such as burns, sunburn and irritated skin. It has antioxidant properties thus protecting the skin.

Inactive Ingredients:

Isopropyl Palmitate, Cetyl Alcohol, Glyceryl Stearate and PEG 100 Stearate, PEG 40 Stearate, Caprylic / Capric Triglyceride, Lecithin, Dimethicone, Vitamin E 3500 IU/oz, Glycerine, Methyl Paraben, Propyl Paraben, Purified Water, Disodium EDTA, Imidurea, Sodium Benzoate.

Indications:

For the treatment of dry, scaly skin (xerosis), ichthyosis vulgaris. Moisturizes and softens skin. For the temporary relief of itching associated with these conditions.

Warnings:

Sun exposure (natural or artificial sunlight) to area of skin treated with Lactic Acid Creme should be minimized or avoided.

Precautions:

FOR EXTERNAL USE ONLY. PATIENT SHOULD BE ADVISED TO KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. Avoid contact with eyes, lips or mucous membranes. Not for use in patients known to be sensitive to any ingredients in this product. A mild, stinging, burning or peeling may occur on sensitive, inflamed or irritated skin areas. If irritation or sensitivity occurs, patient should discontinue use and notify their PODIATRIST, DERMATOLOGIST or PHYSICIAN for appropriate therapy. Caution is advised when used on the face due to the potential for irritation.

The potential for post-inflammatory hypo- or hyperpigmentation has not been studied. Lactic Acid Creme should be given to a pregnant woman only if clearly needed, and caution should be exercised when Lactic Acid Creme is administered to a nursing mother. Safety and effectiveness in pediatric patients have not been established.

Directions:

Apply thoroughly twice a day onto the affected areas or as directed by your PODIATRIST, DERMATOLOGIST or 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:

River's Edge Lactic Acid Creme is available in a 4 oz. (113.4g) plastic jar, NDC 68032-126-04 or an 8 oz. (226.8g) plastic tube, NDC 68032-126-08 .

Store at controlled room temperature 15º - 30ºC (59º - 86ºF).

Rx Only.

Rev. 06/06

Packaging:

LACTIC ACID  lactic acid   cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-126 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTIC ACID (LACTIC ACID) LACTIC ACID 100 mg  in 1 g

Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE   CETYL ALCOHOL   GLYCERYL MONOSTEARATE   POLYOXYL 100 STEARATE   MEDIUM-CHAIN TRIGLYCERIDES   LECITHIN, SOYBEAN   DIMETHICONE   GLYCERIN   METHYLPARABEN   PROPYLPARABEN   EDETATE DISODIUM   WATER   IMIDUREA   SODIUM BENZOATE   ALPHA-TOCOPHEROL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-126-04 113.4 g In 1 JAR None 2 68032-126-08 226.8 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2006	11/30/2011

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010River's Edge Pharmaceuticals, LLC