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 May 1, 2023

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

  • Active ingredients

    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

  • Adverse Reactions 

    KEEP THIS CARTON FOR FULL PRODUCT INFORMATION

    DISTRIBUTED BY: H-E-B, SAN ANTONIO, TN 78204

    LOT NUMBER: ON PACKAGE

    QUESTIONS? 1-888-593-0593

    MADE IN USA WITH US

    AND IMPORTED COMPONENTS.

    WE HOPE YOU ARE SATISFIED WITH

    THIS PRODUCT. IF NOT, WE WILL 

    CHEERFULLY REFUND YOUR MONEY.

  • Principal display panel

    HILL COUNTRY ESSENTIALS

    Diaper Rash Paster

    SKIN PROTECTANT

    40% ZINC OXIDE

    Helps Soothe & Prevent Diaper Rash

    Pomada para Rozaduras

    PROTECTOR DE LA PIEL

    CON OXIDO DE ZINCE 40%

    FREE FROM

    • parapbens
    • phthalates
    • dyes

    NET WT. 4 OZ

    CONT. NET. 113g

    image description

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-020
    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:37808-020-261 in 1 CARTON09/10/2010
    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 finalpart34709/10/2010
    Labeler - H E B (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-020)