ZINC OXIDE OINTMENT [KINRAY INC.]

ZINC OXIDE OINTMENT [KINRAY INC.]
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NDC 63777-222-01, 63777-222-02, 63777-222-03
Set ID 215ce0cf-fd32-45ac-8320-a5c1ae61d8b8
Category HUMAN OTC DRUG LABEL
Packager Kinray Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63777-222-0372 in 1 CASE
    128.34 g in 1 TUBE
    2NDC:63777-222-0172 in 1 CASE
    256.68 g in 1 TUBE
    3NDC:63777-222-0212 in 1 CASE
    3425.1 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/19/2010
    Labeler - Kinray Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma India Private Limited918531450manufacture(63777-222)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(63777-222)

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