DYNAREX ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [DYNAREX CORPORATION]

DYNAREX ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [DYNAREX CORPORATION]
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NDC 67777-119-00, 67777-119-10, 67777-119-20
Set ID 686729af-f96e-a860-e053-2a91aa0af575
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredient

    Zinc Oxide 25%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac
  • 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 again within a few days

    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 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
    • Avoid excessive heat
  • Inactive Ingredients

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

  • Labeling

    1190

    1191

    1192

  • 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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    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)

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