BOUDREAUXS RASH KICKING KIT- zinc oxide kit

Boudreauxs Rash Kicking Kit by

Drug Labeling and Warnings

Boudreauxs Rash Kicking Kit by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ORIGINAL BOUDREAUX’S BUTT PASTE ®

DIAPER RASH OINTMENT

SKIN PROTECTANT (ZINC OXIDE)

Drug Facts

Active ingredient

Zinc oxide, 16%

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 the 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°C to 25°C (59°F to 77°F)
  
• Remove foil seal from the tube’s tip
  
• 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

MAX STRENGTH BOUDREAUX’S BUTT PASTE ®

DIAPER RASH OINTMENT

SKIN PROTECTANT (ZINC OXIDE)

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 the 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°C to 25°C (59°F to 77°F)
  
• Remove foil seal from the tube’s tip
  
• 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 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® RASH KICKING™ KIT

KIT INCLUDES:

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

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

-Boudreaux’s Butt Brush™

INGREDIENTS AND APPEARANCE

BOUDREAUXS RASH KICKING KIT 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0325

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0325-01	1 in 1 CARTON; Type 0: Not a Combination Product	05/25/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	57 g
Part 2	1 TUBE	57 g

Part 1 of 2

BOUDREAUXS 
zinc oxide paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
BALSAM PERU (UNII: 8P5F881OCY)
CASTOR OIL (UNII: D5340Y2I9G)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE (Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		57 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/02/2019

Part 2 of 2

BOUDREAUXS 
zinc oxide paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
BALSAM PERU (UNII: 8P5F881OCY)
CASTOR OIL (UNII: D5340Y2I9G)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE (Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		57 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/25/2018

Labeler - C.B. Fleet Company, Inc. (003119054)