Label: DYNAREX ZINC OXIDE- zinc oxide ointment ointment

  • NDC Code(s): 67777-119-00, 67777-119-10, 67777-119-20
  • Packager: Dynarex Corporation
  • 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 April 8, 2022

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  • Active Ingredient

    Zinc Oxide 25%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat chafed skin associated with diaper rash
    • Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac
  • Warnings

    For External Use Only

    When using this product

    • Avoid contact with eyes

    Stop use and ask a doctor if

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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
    • For poison ivy, oak, and sumac: Apply as needed.
  • Other Information

    • Store at room temperature between 15º-30°C (59º-86°F)
    • Avoid excessive heat
    • Tamper evident. Do not use if seal is damaged.
  • Inactive Ingredients

    Cetomacrogol 1000, Cetostearyl Alcohol, Light Liquid Paraffin, White Soft Paraffin

  • 1190 Label

    1190 BX MASTER1190 Label

  • 1191 Label

    1191 BX MASTER1191 Label

  • 1192 Label

    1192 IN MASTER1192 Label

  • INGREDIENTS AND APPEARANCE
    DYNAREX ZINC OXIDE 
    zinc oxide ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE250 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-119-0028.4 g in 1 TUBE; Type 0: Not a Combination Product03/27/2018
    2NDC:67777-119-1056.7 g in 1 TUBE; Type 0: Not a Combination Product03/27/2018
    3NDC:67777-119-20425 g in 1 JAR; Type 0: Not a Combination Product03/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/27/2018
    Labeler - Dynarex Corporation (008124539)