Label: BOUDREAUXS BABY SHOWER BUNDLE- zinc oxide kit

  • NDC Code(s): 0132-0323-14, 0132-0323-22, 0132-0326-04, 0132-0327-01
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2024

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  • SPL UNCLASSIFIED SECTION

    MAX STRENGTH BOUDREAUX’S BUTT PASTE ®

    DIAPER RASH OINTMENT

    SKIN PROTECTANT (ZINC OXIDE)

    Drug Facts

  • Active ingredient

  • Purpose

    Zinc oxide, 40%...................................................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 the reach of children.

    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°C to 25°C (59°F to 77°F)
    • Remove foil seal prior to use
    • Use with infants, children and adults
    • Will stain clothing and fabric
  • Inactive ingredients

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

  • Questions or comments

    1-855-785-2888 www.buttpaste.com

    BOUDREAUX’S BUTT PASTE ® Butt Barrier

    Protective Ointment

    SKIN PROTECTANT (DIMETHICONE)

    Drug Facts

  • Active ingredient

  • Purpose

    Dimethicone, 1% ...................................................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 the reach of children.

    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°C to 25°C (59°F to 77°F)
    • Remove foil seal from tube’s tip before use
    • For use with infants, children and adults
  • Inactive ingredients

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

  • Questions or comments

    1-855-785-2888 www.buttpaste.com

    BOUDREAUX’S® BUTT BRUSH

    DIAPER CREAM APPLICATOR

    BPA FREE SILICONE

    Instructions:

    Step 1: Apply Butt Paste® on brush head.

    Step 2: Gently brush Butt Paste® on baby’s bottom. For best results, apply thick coat to form a protective barrier.

    Step 3: Clean after each use with a baby wipe. Brush can be disinfected in boiling water as needed. It is also dishwasher safe.

    Suction cup sticks on almost any surface when changing the diaper.

    WARNING:

    The Boudreaux’s Butt Brush™ is not a toy. Use only as directed. Discontinue use if skin shows signs of sensitivity or irritation towards the Boudreaux’s Butt Brush™. Discard or sterilize the Boudreaux’s Butt Brush™ in boiling water if comes in contact with yeast infected skin or an infectious rash.

  • Principal display panel

    BOUDREAUX’S® Baby Shower Bundle

    KIT INCLUDES:

    -Maximum Strength Boudreaux’s Butt Paste® -NET WT. 2oz (57 g)

    -Maximum Strength Boudreaux’s Butt Paste®- NET WT. 14oz (396 g)

    -Boudreaux’s Butt Paste Butt Barrier -NET WT. 4 oz (113 g)

    -Boudreaux’s Butt Brush™

    Principal display panel BOUDREAUX’S® Baby Shower Bundle KIT INCLUDES: -Maximum Strength Boudreaux’s Butt Paste® -NET WT. 2oz (57 g) -Maximum Strength Boudreaux’s Butt Paste®- NET WT. 14oz (396 g) -Boudreaux’s Butt Paste Butt Barrier -NET WT. 4 oz (113 g) -Boudreaux’s Butt Brush™

  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS BABY SHOWER BUNDLE 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0327
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0327-011 in 1 CARTON; Type 0: Not a Combination Product02/01/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 57 g
    Part 21 JAR 397 g
    Part 31 TUBE 113 g
    Part 1 of 3
    BOUDREAUXS 
    zinc oxide cream
    Product Information
    Item Code (Source)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)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0323-2257 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/01/2012
    Part 2 of 3
    BOUDREAUXS 
    zinc oxide cream
    Product Information
    Item Code (Source)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)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0323-14397 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/01/2012
    Part 3 of 3
    BOUDREAUXS BUTT BARRIER 
    dimethicone ointment
    Product Information
    Item 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)  
    GLYCERYL HYDROXYSTEARATE (UNII: UJ6CAW9YNV)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0326-041 in 1 CARTON
    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 DrugM01603/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/01/2024
    Labeler - C.B. Fleet Company, Inc. (003119054)
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