Label: CREAMY DIAPER RASH- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 14, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient
    Zinc oxide 13 g

    Purpose
    Skin protectant
  • INDICATIONS & USAGE

    Uses
    •helps treat and prevent diaper rash
    •protects chafed skin due to diaper rash and helps seal out wetness
  • WARNINGS

    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.
  • DOSAGE & ADMINISTRATION

    Directions
    •change wet and soiled diapers promptly
    •cleanse the diaper area
    •allow to dry
    •apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • STORAGE AND HANDLING

    Other information store between  20⁰ and 25⁰ C (68⁰ - 77⁰ F)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis leaf juice, beeswax,  dimethicone, fragrance, magnesium sulfate, methylparaben, microcrystalline wax, mineral oil, PEG-30 dipolyhydroxystearate, petrolatum, phenoxyethanol,
    potassium hydroxide, propylparaben, sorbitan sesquioleate, tocopheryl acetate, water,
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Johnson + Johnson Consumer Products Company, distributor of Destine
    Made in the USA of US and imported parts
  • ADVERSE REACTIONS

    Distributed By: Geiss, Destin + Dunn
    385 Highway 74 South
    Peachtree, GA 30269
    www.vlauelabels.com
  • PRINCIPAL DISPLAY PANEL

    GoodSense
    Creamy
    Diaper Rash Ointment
    Zinc Oxide • Skin Protectant
    Aloe + Vitamin E • Hypoallergenic • Goes on smooth and wipes off easily
    Compare to Destin Rapid Relief Diaper Rash Cream
    Net WT 4 oz (113 g)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    CREAMY DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-226
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.0 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-226-26.113 kg in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/27/1993
    Labeler - Geiss, Destin + Dunn, Inc (076059836)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture
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