Label: RUGBY ZINC OXIDE- zinc oxide 20% ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin Protectant

  • Uses

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

  • Warnings

    For External Use Only

    When using this product

    • Avoid contact with eyes

    • Do not use over large areas of the body

    Stop use and ask a doctor if

    • Condition worsens

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

    • If 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 (1-800-222-1222) right away.

  • Directions

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

  • Other Information

    • Store at room temperature between 15°-30°C (59°-86°F)

    • Avoid excessive heat

  • Inactive Ingredients

    Cetomacrogol 1000, Cetostearyl Alcohol, Light liquid paraffin (Mineral Oil), Petrolatum

  • Questions and Comments?

    Toll free 1-866-326-1313

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    RUGBY ZINC OXIDE 
    zinc oxide 20% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1393
    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)  
    CETETH-20 (UNII: I835H2IHHX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1393-981 in 1 BOX07/01/2023
    1454 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/01/2023
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(0536-1393)