Label: ZINC OXIDE ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 5, 2017

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  • ACTIVE INGREDIENT

    Section Text

    Active Ingredient                            Purpose

    Zinc Oxide (200mg in each gram)   Skin Protectant

  • Purpose:

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

    For External Use Only

  • When using this product:

    • Do not get in eyes.
  • 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
  • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns
  • 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.

  • 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
  • Inactive Ingredients

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

  • Principal Display

    zinc.jpg

    zinc oxide

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-222-0328.34 g in 1 TUBE; Type 0: Not a Combination Product03/17/2010
    2NDC:67777-222-0156.68 g in 1 TUBE; Type 0: Not a Combination Product03/17/2010
    3NDC:67777-222-02425.1 g in 1 JAR; Type 0: Not a Combination Product03/17/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/16/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Pvt. Ltd.864201135manufacture(67777-222)
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