Label: ZINC OXIDE 20%- 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 September 5, 2018

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
    • dries the oozing and weeping of, poison ivy, poison oak and poison sumac
  • Warnings

    For external use only

    When using this product avoid contact with the eyes

    Stop use and 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.

  • Directions

    apply liberally as often as necessary

    For diaper rash:

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

    Store at controlled room temperature 20°-25°C (68°-77°F).

  • Inactive ingredients

    mineral oil, petrolatum

  • PRINCIPAL DISPLAY PANEL

    28g Label

    56g Label

    454g Label

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 20% 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-040-2828 g in 1 TUBE; Type 0: Not a Combination Product09/17/2018
    2NDC:54162-040-5656 g in 1 TUBE; Type 0: Not a Combination Product09/17/2018
    3NDC:54162-040-16454 g in 1 JAR; Type 0: Not a Combination Product09/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/17/2018
    Labeler - GERITREX LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-040)
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