Label: BOUDREAUXS BUTT BARRIER- dimethicone ointment

  • NDC Code(s): 0132-0326-04
  • Packager: C.B. Fleet Company, Inc.
  • 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 January 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone, 1%

  • 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 necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
  • Other information

    • Store at 15-25° C (59-77° F)
    • Remove seal from jar before use
    • For use with infants, children and adults
  • Inactive ingredients

    Alpha-tocopherol acetate d- (Vitamin E acetate), castor seed oil, glyceryl hydroxystearate, and hydrogenated castor oil

  • Questions

    1-855-785-2888

    www. buttpaste.com

  • Principal Display Panel

    Boudreaux’s Butt Paste®
    Butt Barrier
    Protective Ointment
    Skin protectant / Dimethicone 1%

    NET WT. 4 oz (113 g)                  

    Boudreaux’s Butt Paste® Butt Barrier Protective Ointment Skin protectant / Dimethicone 1% NET WT. 4 oz (113 g)

  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS BUTT BARRIER 
    dimethicone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERYL HYDROXYSTEARATE (UNII: UJ6CAW9YNV)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0326-041 in 1 CARTON03/01/2022
    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 finalpart34703/01/2022
    Labeler - C.B. Fleet Company, Inc. (003119054)
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