Label: LACTIC ACID- lactic acid cream

  • NDC Code(s): 58980-915-40
  • Packager: Stratus Pharamceuticals, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 10/09

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    For dry itchy skin and minor skin irritation

    FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

    Rx only

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  • 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.

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  • 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.

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  • CONTRAINDICATION

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

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  • WARNINGS

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

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  • 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.

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  • 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.

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  • 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.

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  • SPL UNCLASSIFIED SECTION

    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

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  • 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)

    Principal Display Panel - 113.4g Label
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  • INGREDIENTS AND APPEARANCE
    LACTIC ACID 
    lactic acid cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-915
    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
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-915-40 113.4 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved other 01/16/2009
    Labeler - Stratus Pharamceuticals, Inc (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc 104283945 MANUFACTURE
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