Label: ZINC OXIDE 20% ointment

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

Drug Label Information

Updated April 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
    ■ Helps treat and prevent diaper rash
    ■ Protects chafed skin due to diaper rash and helps seal out wetness

  • Warnings

    For external use only

  • When using this product

    do not get into eyes.

  • 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

  • Keep out of reach of children.

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

  • Directions

    ■ For poison ivy, oak & sumac: apply as needed

    ■ For Diaper Rash

    • 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 bed time or anytime when exposure to wet diapers may be prolonged
  • Other information

    ■ Store at 15°C – 30°C (59°F – 86°F)

  • Inactive ingredients

    ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Bionpharma Inc.
    Princeton, NJ 08540
    MADE IN INDIA

    L0000798

    KBP0581L-0

    R0324
    GUJ/DRUGS/G/25/2134

  • PRINCIPAL DISPLAY PANEL

    NDC 69452-450-58

    • dye-free • paraben-free

    • phthalate-free • fragrance-free

    a+ health TM

    healing ointment

    zinc oxide 20% / skin protectant
    • protects chafed skin due to diaper rash and helps seal out wetness
    • dries the oozing and weeping of poison ivy, oak and sumac

    net wt. 15 oz

    image001

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 20% 
    zinc oxide 20% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-450
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-450-58425 g in 1 JAR; Type 0: Not a Combination Product04/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01604/01/2024
    Labeler - Bionpharma Inc (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176manufacture(69452-450)
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