Label: ZINC OXIDE- zinc oxide ointment

  • NDC Code(s): 0168-0062-02, 0168-0062-16, 0168-0062-31
  • Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

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

  • Active Ingredient:

    Zinc Oxide (200 mg)

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  • Purpose:

    Skin protectant

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  • INDICATIONS & USAGE

    Uses:

    • helps treat and prevent diaper rash
    • dries the oozing and weeping of:
    • poison ivy
    • poison oak
    • poison sumac
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  • WARNINGS

    Warnings:

    If condition worsens or dose not improve within seven days, consult physician.

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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    FOR EXTERNAL USE ONLY

    AVOID CONTACT WITH EYES

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  • DOSAGE & ADMINISTRATION

    Directions:

    • For diaper rash:
    • change wet and soiled diapers promptly, allow to dry
    • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. To dry the oozing and weeping of poison ivy, poison oak or poison sumac:
    • apply ointment liberally as often as needed
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  • SPL UNCLASSIFIED SECTION

    Other information:

    • do not use if seal is punctured or is not visible
    • use cap to puncture seal
    • store at temperature
    • do not exceed 30° C (86° F)
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  • Inactive Ingredients

    mineral oil, white petrolatum, white wax

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  • SPL UNCLASSIFIED SECTION

    Questions or comments? call toll free 1-800-645-9833

    E. FOUGERA & CO.

    A division of Fougera Pharmaceuticals Inc.

    Melville, NY 11747

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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    NDC 0168-0062-31

    Fougera®

    Zinc Oxide Ointment USP

    NET WT 28.35g (1 Oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    NDC 0168-0062-31

    Fougera®

    Zinc Oxide Ointment USP

    Skin Protectant

    To reliably help soothe and protect chafed skin.

    INDICATION: Helps and prevent diaper rash. Protects chafed skin due to diaper rash and helps protect from wetness. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.

    NET WT 28.35g (1 Oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0062-16

    Zinc Oxide
    Ointment USP

    NET WT 453.6 g (1 lb)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL
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  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0168-0062
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL  
    PETROLATUM  
    WHITE WAX  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0062-31 1 in 1 CARTON
    1 28.35 g in 1 TUBE
    2 NDC:0168-0062-02 1 in 1 CARTON
    2 56.70 g in 1 TUBE
    3 NDC:0168-0062-16 453.6 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/01/1968
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
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