Label: ZINC OXIDE 20%- zinc oxide ointment

  • NDC Code(s): 68016-159-02
  • Packager: Pharmacy Value Alliance, LLC
  • 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 May 9, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash - helps protect skin from wetness
    • Protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
    • Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
  • 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

    • 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 betime or anytime when exposure to wet diapers may be prolonged
  • Other Information

    • Store at controlled room temperature 20° - 25°C (68° - 77°F)
  • Inactive Ingredients

    Mineral Oil, Petrolatum

  • Distributed By:

    Pharmacy Value Alliance, LLC.

    407 East Lancaster Avenue, Wayne, PA. 19087

    www.emersongroup.com

    Product of PRC

  • Packaging

    Emerson Zinc Oxide

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 20% 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-159
    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:68016-159-021 in 1 BOX07/19/2016
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/19/2016
    Labeler - Pharmacy Value Alliance, LLC (101668460)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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