LACTINOL - lactic acid lotion 
Pedinol Pharmacal, Inc.

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LACTINOL™ LOTION
(lactic acid 10%)

NDC 0884-5292-12

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.

INGREDIENTS:

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

INDICATIONS

Lactinol Lotion is indicated for moisturizing, softening 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 area of skin treated with Lactinol Lotion 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 or mucous membranes. Not for use in patients known to be sensitive to any of the ingredients in Lactinol Lotion. 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 Lotion should be given to a pregnant woman only if clearly needed, and caution should be exercised when Lactinol Lotion 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 12 oz. (354.84 mL) bottle with pump dispenser.

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 0408

PRINCIPAL DISPLAY PANEL - Bottle Label

APPROVED
AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

NDC 0884-5292-12

LACTINOL™
LOTION

RELIEF OF DRY, SCALY,
ITCHING SKIN

Rx Only

PEDiNOL
PHARMACAL INC

NET WT. 12 OZ. (354.84mL)

LACTINOL  lactic acid   lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0884-5292 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

Inactive Ingredients Ingredient Name Strength water   Isopropyl Palmitate   Cetyl Alcohol   Glyceryl Monostearate   Polyoxyl 100 Stearate   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 0884-5292-12 354.84 mL In 1 BOTTLE, PUMP None 2 0884-5292-16 473.12 mL In 1 BOTTLE, PUMP None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/01/1992	10/26/2009

Labeler - Pedinol Pharmacal, Inc. (064737125)

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

Revised: 11/2009Pedinol Pharmacal, Inc.