LACTIC ACID 10% E CREAM

For dry itchy skin and minor skin irritation

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Rx only

DESCRIPTION

Lactic Acid, an alpha-hydroxy acid, is a natural skin-moisturizing agent. It has beneficial effects on dry skin (xerosis) and in severe discomfort of hyperkeratotic conditions.

INGREDIENTS

Active Ingredient: Lactic Acid 10%.

Inactive Ingredients: Purified Water, Vitamin E 3500IU/ OZ, Isopropyl Palmitate, Cetyl Alcohol, Glyceryl Stearate and PEG 100 Stearate, PEG-40 Stearate, Caprylic/ Capric Triglyceride, Lecithin, Dimethicone, Glycerin. Methylparaben Propylparaben, Disodium EDTA, Imidurea, Sodium Benzoate.

INDICATIONS AND USAGE

Lactic Acid 10% E Cream is a white rich moisturizer for dry skin (xerosis) and is indicated to moisturize and soften dry, itchy skin and minor skin irritation.

CONTRAINDICATION

Not for use in patients know to be sensitive to the active or inactive ingredients in Lactic Acid 10% E Cream.

WARNINGS

Minimize or avoid sun exposure to areas of the skin treated with Lactic Acid 10% E Cream.

PRECAUTIONS

FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN. Do not use in or near eyes, lips or mucous membranes. Patient may experience mild stinging or burning and peeling may occur on sensitive or irritated skin areas. If sensitivity or irritation occurs, immediately discontinue use and consult a medical professional. Caution is advised when used on the face due to the potential for irritation. The potential for post-inflammatory hypo-hyperpigmentation has not been studied.

Avoid administering Lactic Acid 10% E Cream to pregnant women unless clearly required and use caution in its use for nursing mothers. Safety and effectiveness in pediatric patients have not been established.

DOSAGE AND ADMINISTRATION

Apply thoroughly twice daily on affected areas or as prescribed by a 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

4oz (113.4g) net wt. polypropylene jar NDC NDC 58980-915-40

STORAGE

Store at controlled room temperature 15° - 30°C (59° - 86°F). See bottom of jar for lot number and expiration date.

Distributed by
STRATUS
PHARMACEUTICALS INC

Manufactured for
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6727

Customer Service
Telephone: 1-800-442-7882
Fax: 305-254-6875

JG LAC02008-1210

PRINCIPAL DISPLAY PANEL - 113.4g Label

NDC 58980-915-40

LACTIC ACID
10% E CREAM

For dry, itchy skin
and minor skin irritation

Rx only

For Topical Use Only

Net WT. 4.0 oz. (113.4g)

LACTIC ACID
lactic acid cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:58980-915
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	11.34 g in 113.4 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58980-915-40	113.4 g in 1 JAR; Type 0: Not a Combination Product	01/16/2009	05/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		01/16/2009	05/03/2017

Labeler - Stratus Pharamceuticals, Inc (789001641)

Revised: 11/2017

Document Id: 5be89506-956d-42dd-a6b6-c9d1bfd94599

Set id: 704aa3e3-c2f0-49d9-9ada-f65efde61aae

Version: 2

Effective Time: 20171130

Stratus Pharamceuticals, Inc