ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [PHARMACY VALUE ALLIANCE, LLC]

ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [PHARMACY VALUE ALLIANCE, LLC]
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NDC 68016-159-02
Set ID 38018e3f-3778-01d1-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Pharmacy Value Alliance, LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • 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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