Label: ZINC OXIDE ointment

  • NDC Code(s): 50157-333-45
  • Packager: ​BRANDS INTERNATIONAL
  • 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 March 15, 2023

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  • Active ingredient

    Zinc Oxide (20% w/w)

  • Purpose

    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 into eyes
    • do not use over large areas of the body
  • 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 any time when exposure to wet diapers may be prolonged
    • for poison ivy, oak, sumac
    • apply ointment liberally as often as needed
  • Other information

    • store at 59°-86° F (15°-30°C)
    • avoid excessive heat
  • Inactive ingredients

    mineral oil, petrolatum

  • PACKAGE LABEL

    zinc

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-333
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-333-45454 g in 1 TUBE; Type 0: Not a Combination Product03/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/15/2023
    Labeler - ​BRANDS INTERNATIONAL (243748238)
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