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Zinc Oxide (Kinray Inc.)

Available Formats

Dosage Form Package Information Links
OINTMENT 72 TUBE in 1 CASE (63777-222-03) > 28.34 g in 1 TUBE Label Information
OINTMENT 72 TUBE in 1 CASE (63777-222-01) > 56.68 g in 1 TUBE Label Information
OINTMENT 12 JAR in 1 CASE (63777-222-02) > 425.1 g in 1 JAR Label Information

Complete Zinc Oxide Information

  • ACTIVE INGREDIENT

    Section Text

    Active Ingredient                            Purpose

    Zinc Oxide (200mg in each gram)   Skin Protectant


  • Purpose

    Helps treat and prevent diaper rash.
    Dries the oozing and weeping of;
    poison ivy
    poison oak
    poison sumac


  • Warnings:

    For External Use Only


  • When using this product:

    • Do not get in eyes.

  • Stop use and ask a doctor if:

    • conditions worsens
    • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician.
    • over large areas of the body
    • if you are allergic to any of these ingredients

  • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • Inactive Ingredient 

    Inactive ingredients: Light mineral oil, white petrolatum


  • Dosage and Administration

    For diaper rash:

    • change wet and soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

    For poison ivy, poison oak, poison sumac:

    • apply liberally as often as needed

  • Indications and Usage

    • do not use if seal is punctured or if not visible
    • avoid excessive heat
    • store at room temperature 15 deg to 30 deg C, 59 deg F to 86 deg F

  • Principal Display Panel

    Zinc Oxide Ointment

    zinc_oxide_ointment.jpg

    zinc_oxide_ointment


  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-222
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63777-222-03 72 in 1 CASE
    1 28.34 g in 1 TUBE
    2 NDC:63777-222-01 72 in 1 CASE
    2 56.68 g in 1 TUBE
    3 NDC:63777-222-02 12 in 1 CASE
    3 425.1 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 04/19/2010
    Labeler - Kinray Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    Name Address ID/FEI Business Operations
    Galentic Pharma India Private Limited 918531450 manufacture(63777-222)
    Establishment
    Name Address ID/FEI Business Operations
    Blossom Pharmaceuticals 677381470 manufacture(63777-222)