Label: BOUDREAUXS BUTT DIAPER RASH MAX STRENGTH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • 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

    • avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens or does not improve after 7 days

    Keep out of reach of children

    • to prevent accidental ingestion
    • If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately
  • Directions

    • Change wet and soiled diaper immediately
    • Cleanse the diaper area and allow to dry
    • Apply ointment liberally and as often as neessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
  • Other information

    • Store at 15°C-25°C (59°F-77°F)
    • Remove foil seal from tube's tip before use
    • Use with infants, children and adults
    • Will stain clothing and fabric
  • Inactive ingredients

    myroxylon pereirae (balsam peru) resin, mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil

  • Questions?

    1-855-785-2888

    www.buttpaste.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS BUTT DIAPER RASH MAX STRENGTH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63471-3001(NDC:0132-0323)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    BALSAM PERU (UNII: 8P5F881OCY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63471-3001-21 in 1 CARTON12/02/2019
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/02/2019
    Labeler - Geodis Logistics LLC (877844097)
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