Label: ZINC OXIDE- zinc oxide ointment cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 22, 2017

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  • Warnings

    For external use only.• Avoid contact with eyes.•

    Stop use & ask a doctor if condition worsens or does not improve

    within 7 days.• Keep out of reach of children.•

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

  • Uses

    Helps treat & prevent diaper rash.

    Protects chafed skin assoicated with diaper rash & helps

    protect from wetness. Effective for treating poison ivy,

    poison oak & sumac.

  • Inactive Ingredients

    Light Mineral Oil & White Petrolatum

  • Active Ingredients (In each gram)

    Zinc Oxide 20% Skin Protectant

  • Directions

    Gently cleanse affected area and allow to dry before application.

    Apply ointment liberally & as often as necessary.

    For diaper rash, chage wet and soiled diapers promptly.

    Use with each diaper change, especially when exposure to wet

    diapers may be prolonged.

  • Other Information

    Lot Number & Expiration Date; see bottom of container.

    Store at controlled room temperature (59ºF - 86ºF).

  • KEEP OUT OF REACH OF CHILDREN

    For external use only.• Avoid contact with eyes.•

    Stop use & ask a doctor if condition worsens or does not improve

    within 7 days.• Keep out of reach of children.•

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

  • PURPOSE

    Helps, treats and prevents diaper rash. Protects chafed skin associaed with diaper rash & helps protect from wetness.

    Effective in treating poison ivy, poison oak and sumac.

  • PRINCIPAL DISPLAY PANEL

    Zinc Oxide OintmentGentell Zinc Oxide

  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61554-234(NDC:71395-715)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.2 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61554-234-0128.3 kg in 1 TUBE; Type 0: Not a Combination Product03/24/2017
    2NDC:61554-234-00454 kg in 1 JAR; Type 0: Not a Combination Product03/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/03/2014
    Labeler - Gentell, Inc,. (170967876)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gentell,Inc.170967876repack(61554-234)
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