Label: DIAPER RASH- zinc oxide paste

  • 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 April 24, 2023

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  • Active ingredient

    Zinc oxide 40%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due 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 soilded 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

    store between 20⁰ and 25⁰C (68⁰ and 77⁰F)

  • Inactive ingredients

    petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

  • Disclaimer

    Made in the U.S.A. with U.S. an foreign parts.

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Destine Maximum Strength 40% Zince Oxide Diaper Rash Paste.

  • Adverse reaction

    DISTRIBUTED BY

    OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100%

    Quality

    Guaranteed

    (888)309-9030

  • Principal display panel

    *Compare to Desitin Maximum Strength Diaper Rash Paste

    Gentle STEPS

    maximum strength

    diaper rash paste

    Skin Protectant - Zinc Oxide 40%

    Helps heal, soothe & prevent diaper rash

    Hypoallergenic

    Paraben, Phthalate & Quaternium 15 free

    NET WT 4 OZ (113 g)

    image description

  • Principal display panel

    DG baby

    maximum strength

    diaper rash paste

    Skin Protectant

    Zinc Oxide 40%

    Quaternium-15 & Paraben Free

    Compare to Desitin Maximum Strength Diaper Rash Paste*

    • Helps heal, soothe and prevent rash

    NET WT 4 OZ (113 g)

    image description

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-020-261 in 1 CARTON05/10/2012
    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 finalpart34705/10/2012
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-020)
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