ZINC OXIDE OINTMENT [ULTRA SEAL CORPORATION]

ZINC OXIDE OINTMENT [ULTRA SEAL CORPORATION]
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NDC 42213-365-48, 42213-365-56
Set ID e45ac82c-508c-4c41-ba2c-f48d36bc63fe
Category HUMAN OTC DRUG LABEL
Packager Ultra Seal Corporation
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredients Zinc oxide 20%

  • PURPOSE

    Purpose: Skin Protectant

  • INDICATIONS & USAGE

    Dries the oozing and weeping of poison ivy, poison oak, and sumac.  Helps treat/prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness.

  • WARNINGS


    For external use only. When using this product, avoid contact with eyes.

    Stop use and ask a doctor if condition worsens or does not improve in 7 days




  • DOSAGE & ADMINISTRATION

    Directions:  Apply liberally as often as necessary.  For diaper rash: Change wet and soiled diapers promptly.  Cleanse the diaper area and allow to dry.  Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.


  • INACTIVE INGREDIENT

    Inactive Ingredient:  White Petrolatum

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    Zn o 2 oz tube

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-365
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42213-365-481 in 1 CARTON05/03/2012
    1NDC:42213-365-5656 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/03/2012
    Labeler - Ultra Seal Corporation (085752004)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004manufacture(42213-365)

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