Label: DIAPER RASH- zinc oxide cream 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Active ingrdients

    Active ingredient

    Zinc oxide 13%

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  • Purpose

    Purpose

    Skin protectant

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  • Uses

    Uses

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

    Warnings

    For external use only

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  • When using this product

    When using this product

    • do not get into eyes
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  • Stop use

    Stop use and ask a doctor if

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

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

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  • Directions

    Directions

    • change wet ad 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.
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  • other information

    Other information2.2ex0em2.2ex0emstore between 20º and 25ºC (68º and 77º F)

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  • Inactive ingredients

    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, tocoperyl acetate, water

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  • Questions

    Questions? Call 1-888-309-9030

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  • Disclaimer

    This product is not manufactured or distributed by Johnson + Johnson Consumer Products Company, distributor of Desitin

    Made in the U.S.A. of U.S. and imported parts

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  • Adverse reactions

    DISTRIBUTED BY

    DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

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  • Principal display panel

    DG baby

    Diaper

    Rash

    Cream

    Skin Protectant

    Zinc Oxide 13%

    • Goes on smoothly
    • Helps heal, soothe and prevent diaper rash

    Compare to Desitin

    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 LABEL Item Code (Source) NDC:55910-148
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.113 kg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    YELLOW WAX  
    DIMETHICONE  
    ETHYLHEXYLGLYCERIN  
    MAGNESIUM SULFATE  
    MICROCRYSTALLINE WAX  
    MINERAL OIL  
    PEG-30 DIPOLYHYDROXYSTEARATE  
    PETROLATUM  
    PHENOXYETHANOL  
    POTASSIUM HYDROXIDE  
    SORBITAN SESQUIOLEATE  
    .ALPHA.-TOCOPHEROL ACETATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-148-26 1 in 1 CARTON
    1 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 07/29/2011
    Labeler - DolGenCorp, LLC (068331990)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(55910-148)
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