Label: ZINC OXIDE ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 July 29, 2013

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  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash
    • helps seal out wetness
  • WARNINGS

    For external use only.

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur within a few days.

    Keep out of reach of children.

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

  • Directions

    • change wet or soiled diapers promptly
    • clean the diaper area
    • allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.
  • Other Information

    • store at 20-25°C (68-77°F)
  • Inactive Ingredients

    bees wax, BHT, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-100-021 in 1 BOX
    156.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2013
    Labeler - Topco Associates LLC (006935977)
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