Label: ZINC OXIDE- zinc oxide ointment 

  • Label RSS
  • NDC Code(s): 67777-222-01, 67777-222-02, 67777-222-03
  • Packager: Dynarex Corporation
  • 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 09/14

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  • ACTIVE INGREDIENT

    Section Text

    Active Ingredient                            Purpose

    Zinc Oxide (200mg in each gram)   Skin Protectant

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  • Purpose:

    • Helps treat and prevent diaper rash.
    • Dries the oozing and weeping of;
    • poison ivy
    • poison oak
    • poison sumac
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  • Warnings:

    For External Use Only

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  • When using this product:

    • Do not get in eyes.
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  • Stop use and ask a doctor if:

    • conditions worsens
    • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician.
    • over large areas of the body
    • if you are allergic to any of these ingredients
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  • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions:

    For diaper rash:

    • change wet and soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

    For poison ivy, poison oak, poison sumac:

    • apply liberally as often as needed
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  • Inactive Ingredients

    Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

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  • Principal Display

    zinc oxide

    zinc.jpg

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  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67777-222
    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
    CETOSTEARYL ALCOHOL  
    CETETH-20  
    LIGHT MINERAL OIL  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-222-03 72 in 1 CASE
    1 28.34 g in 1 TUBE
    2 NDC:67777-222-01 72 in 1 CASE
    2 56.68 g in 1 TUBE
    3 NDC:67777-222-02 12 in 1 CASE
    3 425.1 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/16/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    Name Address ID/FEI Business Operations
    Galentic Pharma (India) Pvt. Ltd. 864201135 manufacture(67777-222)
    Establishment
    Name Address ID/FEI Business Operations
    Blossom Pharmaceuticals 677381470 manufacture(67777-222)
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