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 January 26, 2018

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  • 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

  • Packaging

    Zinc PDP

  • 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:69396-021-011 in 1 BOX01/04/2018
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/04/2018
    Labeler - Trifecta Pharmaceuticals USA (079424163)
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