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.

Inactives:

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

Indications:

For moisturizing and softening dry, scaly skin (xerosis), ichthyosis vulgaris and for the temporary
relief of itching associated with these conditions.

Contraindications:

Not for use in patients known to be sensitive to any of the ingredients in Lactic Acid Lotion.

Warnings:

Sun exposure (natural or artificial sunlight) to area of skin treated with Lactic Acid Lotion
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 Lotion should be given to a pregnant woman only if clearly needed, and caution
should be exercised when Lactic Acid 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.

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.

River's Edge Lactic Acid Lotion is available in a 12 oz. (354.84mL) plastic bottle,
NDC 68032-125-12 or a 16 oz. (473.12mL) plastic bottle, NDC 68032-125-16.

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

Rx Only.

Logo

Rev. 10/06

Drug Facts

ACTIVE INGREDIENT
Purpose
Lactic Acid 10% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Moisturizer for dry skin (xerosis)

USES
• treats dry, scaly skin (xerosis)
• moisturizes and softens dry, scaly skin
• temporary relief of itching associated with these conditions

WARNINGS
• for external use only
• avoid sun exposure to area treated

PRECAUTIONS
• do not use in or near eyes, lips and mucous membranes
• stop use and ask PODIATRIST, DERMATOLOGIST or PHYSICIAN if irritation
or sensitivity occurs
• do not use on face due to potential irritation

Keep out of reach of children

DIRECTIONS
• apply thoroughly twice a day onto affected areas

OTHER INFORMATION
• store at controlled room temperature 15º-30ºC (59º-86ºF)
• see package insert for additional information
• 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.

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

Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024

REV. 06/06

Label

LACTIC ACID
lactic acid lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68032-125
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lactic Acid (Lactic Acid)	Lactic Acid	.1 mL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68032-125-12	354.84 mL In 1 BOTTLE, PLASTIC	None
2	68032-125-16	473.12 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2006	02/28/2010

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

Revised: 12/2009River's Edge Pharmaceuticals, LLC