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 February 9, 2023

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  • Active ingredient

    Zinc oxide 13%

  • Purpose

    Skin protectant

  • Uses

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

  • 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
  • Other information

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

  • Inactive ingredients

    water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol

  • claims

    * This product is not manufactred or distributed by Johnson & Johnson Consumer Products Company, distributor of Desitin Rapid Relief Zinc Oxide

    Diaper Rash Cream

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

    Best Choice 100% Guaranteed

    www.bestchoicebrand.com

  • principal display panel

    COMPARE TO DESITIN RAPID RELIEF DIAPER RASH CREAM*

    Best Choice

    Zinc Oxide

    DIAPER RASH CREAM SKIN PROTECTANT

    DERMATOLOGITST TESTED

    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:63941-226
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE130 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    dimethicone (UNII: 92RU3N3Y1O)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MAGNESIUM SULFATE MONOHYDRATE (UNII: E2L2TK027P)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-226-261 in 1 CARTON12/30/2020
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/30/2020
    Labeler - Valu Merchandisers (868703513)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63941-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63941-226)
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