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.

RELogo

Rev. 06/06

Package Label & Insert:

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

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
and Sodium Benzoate.

USES
• Treats dry, scaly skin (xerosis) and ichthyosis vulgaris. • Moisturizes and softens
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. • A mild stinging, burning or peeling may occur on sensitive, inflamed or irritated
skin areas. The potential for post-inflammatory hypo- or hyper-pigmentation has not been studied.
• Should be given to a pregnant woman only if clearly needed and caution should be exercised when administered
to a nursing mother. • Safety and effectiveness in pediatric patients has not been established.

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.

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


Label

Insert


LACTIC ACID 
10% lactic acid creme   cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-126
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lactic Acid (Lactic Acid) Lactic Acid.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-126-04113.4 g In 1 JARNone
268032-126-08226.8 g In 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2006

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2009River's Edge Pharmaceuticals, LLC