Label: ZINC OXIDE- skin protectant ointment

  • NDC Code(s): 68001-532-45, 68001-532-46, 68001-533-50
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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  • Active Ingredient

    Zinc Oxide 20% w/w

  • Purpose

    Skin Protectant

  • Uses

    • Dries the oozing and weeping of poison: • Ivy • Oak • Sumac

  • Warnings

    For External Use Only

    When using this product

    • Do not get into eyes

    • Do not use over large areas of the body

    Stop use and ask a doctor if

    • The condition worsens

    • Symptoms last more than 7 days or clear up and occur again within a few days

    • You are allergic to any of these ingredients

    Keep out of reach of children

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

  • Directions

    For poison ivy, oak, and sumac: apply as needed.

  • Other Information

    • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
    • Store at room temperature.
      • Preserve in well-closed container.
      • See crimp of tube or carton for Lot number and Expiry Date.
  • Inactive Ingredients

    Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 20, White Petrolatum.

  • Questions?

    Contact 1-800-707-4621

    Gopaldas Visram & Company Limited.

    Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

    Mahape, Navi Mumbai- 400710.

    For BluePoint Laboratories

  • Tube and carton 30 g

    Carton label 30 gTube label 30 g

  • Tube and carton 60 g

    Carton label 60 gTube label 60 g

  • Jar Label 454 g

    Jar Label 454 g

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-532
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-532-451 in 1 CARTON03/24/2022
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68001-532-461 in 1 CARTON03/24/2022
    260 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/24/2022
    ZINC OXIDE 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-533
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-533-50454 g in 1 JAR; Type 0: Not a Combination Product03/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/24/2022
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-532, 68001-533)
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