LACTINOL-E - lactic acid cream 
Pedinol Pharmacal, Inc.

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LACTINOL-E® CREME
(lactic acid 10%)

NDC 0884-4990-04
NDC 0884-4990-08

RELIEF OF DRY, SCALY ITCHING SKIN
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION

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.

INGREDIENTS:

Active: Lactic Acid 10%. Inactives: Water, Vitamin E 3500 IU/oz., Glyceryl Stearate (and) PEG-100 Stearate, Cetyl Alcohol, Glycerine, PEG-40 Stearate, Caprylic Capric Triglyceride, Lecithin, Dimethicone, EDTA, Methylparaben, Propylparaben, Diazolidinyl Urea, Sodium Benzoate.

INDICATIONS

Lactinol-E Creme is indicated for moisturizing, softening of dry, scaly skin (Xerosis), ichthyosis vulgaris and for the temporary relief of itching associated with these conditions.

APPROVED BY THE AMERICAN PODIATRIC MEDICAL ASSOCIATION.

WARNING

Sun exposure (natural or artificial sunlight) to areas of the skin treated with Lactinol-E Creme should be minimized or avoided.

PRECAUTIONS

FOR EXTERNAL USE ONLY. PATIENTS SHOULD BE ADVISED TO KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. Not for use in patients known to be sensitive to any of the 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.

Lactinol-E Creme should be given to a pregnant woman only if clearly needed, and caution should be exercised when Lactinol-E 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.

HOW SUPPLIED

Available in a 4 oz. (113.4g) plastic jar and an 8 oz. (226.8g) tube.

Store at controlled room temperature 15° - 30°C (59° - 86°F).

Rx ONLY.

Manufactured for:
PEDINOL PHARMACAL INC.
30 Banfi Plaza No.
Farmingdale, NY 11735

REV 504

PRINCIPAL DISPLAY PANEL - Jar Label

NDC 0884-4990-04

LACTINOL-E®
CREME

RELIEF OF DRY, SCALY ITCHING SKIN
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE

Rx Only

PEDiNOL
PHARMACAL INC.

NET WT. 4 OZ. (113.4g)

LACTINOL-E  lactic acid   cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0884-4990 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lactic Acid (Lactic Acid) Lactic Acid 11.34 g  in 113.4 g

Inactive Ingredients Ingredient Name Strength water   Alpha-Tocopherol Acetate   Glyceryl Monostearate   Polyoxyl 100 Stearate   Cetyl Alcohol   Glycerin   Polyoxyl 40 Stearate   Lecithin, Soybean   Dimethicone   Edetic Acid   Methylparaben   Propylparaben   Diazolidinylurea   Sodium Benzoate

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0884-4990-04 113.4 g In 1 JAR None 2 0884-4990-08 226.8 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/01/1991	11/10/2009

Labeler - Pedinol Pharmacal, Inc. (064737125)

Establishment
Name	Address	ID/FEI	Operations
Corwood Laboratories, Inc.		045860715	ANALYSIS, MANUFACTURE

Revised: 11/2009Pedinol Pharmacal, Inc.