Label: DIAPER RASH- zinc oxide cream

  • 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 March 16, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient

    Zinc oxide 13%

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  • Purpose

    Skin protectant

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  • Use

    • helps treat and prevent diaper rash
    • protects chafed sking die to diaper rash and helps seal out wetness
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  • Warnings

    For external use only

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  • When using this product

    • do not get into eyes
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  • Stop use

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
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  • Keep out of reach of children

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

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  • Directions

    • change wet and soiled diaper promplty
    • 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
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  • Other information

    store between 20º and 25ºC (68º and 77º F)

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  • Inactive ingredients

    aloe barbadensis leaf juice, beeswax, dimethicone, ethylhexylglycerin, fragrance, magnesium sulfate, microcrystalline wax, mineral oil, PEG-30
    dipolyhydroxystearate, petrolatum, phenoxyethanol, potassium hydroxide, sorbitan sesquioleate, tocopheryl acetate, water

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  • claims

    Satisfaction guaranteed - Or we'll replace it or give you your money back.  For questions or comments or to report an undesired reaction or effect, please call 1-800-888-287-1915

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  • Adverse Reactions

    Made in the USA with US and imported parts

    Distributed by: Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

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  • Disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Destine Rapid Relief

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  • Principal Display Panel

    NDC 49035-001-26

    Equate

    Compare to

    Destin

    Rapiod Relief

    Active

    Ingredients

    Creamy

    Diaper Rash Relief

    Zinc Oxide Diaper Rash Ointment

    Skin Protectant

    • Goes on smoothly & wipes off easily
    • Helps heal, soothe & prevent diaper rash
    • Hypoallergenic
    • Fresh Scent
    • Paraben Phthalate and Quaternium 15 free

    NET WT

    4 OZ (113 g)

    image description

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  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 130 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-001-26 1 in 1 CARTON 01/31/1994
    1 113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/31/1994
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(49035-001)
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