ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]

ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]
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NDC 69396-021-02
Set ID 63b551fc-7d16-c099-e053-2a91aa0a5f2c
Category HUMAN OTC DRUG LABEL
Packager Trifecta Pharmaceuticals USA
Generic Name
Product Class
Product Number
Application Number PART347
  • Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin Protectant

  • Uses

    • Protects skin
    • Protects and releives chafed skin due to diaper rash - helps seal out wetness
    • Dries the oozing and weeping of poison ivy, oak and sumac
  • Keep out of the reach of children

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

  • Warnings

    For External Use Only

    • When using this product avoid contact with eyes
    • Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.
  • Directions

    • Apply ointment liberally as often as necessary
    • For the treatment of diaper rash, change wet and soiled diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged
  • Other Information

    • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Inactive Ingredients

    Mineral Oil, Petrolatum

  • Distributed By:

    Trifecta Pharmaceuticals USA, LLC.

    101 NE Third Avenue, Ste. 1500

    Ft. Lauderdale, FL. 33301, USA.

    Product of PRC

    www.trifecta-pharma.com

  • PRINCIPAL DISPLAY PANEL

    Globe Zinc Oxide Ointment

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 20% 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-021-021 in 1 BOX01/26/2018
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/26/2018
    Labeler - Trifecta Pharmaceuticals USA (079424163)

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