Label: DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 30, 2013

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  • Active ingrdients

    Active ingredient

    Zinc oxide 13%

  • Purpose

    Purpose

    Skin protectant

  • Uses

    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

    When using this product

    • do not get into eyes
  • 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
  • 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

  • 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.
  • other information

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

  • 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

  • Questions

    Questions? Call 1-888-309-9030

  • 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

  • Adverse reactions

    DISTRIBUTED BY

    DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • 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

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-148
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.113 kg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM SULFATE (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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-148-261 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34707/29/2011
    Labeler - DolGenCorp, LLC (068331990)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(55910-148)
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