Label: DIAPER RASH- zinc oxide paste

  • NDC Code(s): 49035-952-26, 49035-952-43
  • Packager: Wal-Mart Stores
  • 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 November 14, 2022

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  • Active ingredient

    Zinc oxide 40%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to the 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 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

  • Questions?

    Call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    Walmart Inc.,

    Bentonville, AR 72716

  • principal display panel

    NDC 49035-952-43

    equate

    Compare to Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste*

    Diaper Rash Ointment

    40% ZINC OXIDE

    Skin Protectant

    NET WT 16 OZ (1LB) 453g

    image description

  • principal display panel

    Parent's Choice

    Diaper Rash Ointment

    Maximum Strength

    40% ZINC OXIDE

    Skin Protectant

    Helps Heal, Soothe & Prevent Diaper Rash

    • Hypoallergenic
    • Maximum Strength Formula for Diaper Rash Care
    • Paraben, Phthalates & Quaternium 15 Free
    • This Product Does Not Contain Talc

    COMPARE TO

    DESTIN MAXIMUM STRENGTH ACTIVE INGREDIENT

    NET WT 4 OZ (113g)

    image description

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-952
    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:49035-952-261 in 1 CARTON03/09/2016
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49035-952-43453 g in 1 JAR; Type 0: Not a Combination Product03/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/09/2016
    Labeler - Wal-Mart Stores (051957769)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(49035-952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(49035-952)
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