BOUDREAUXS BUTT BARRIER- dimethicone ointment

Boudreauxs Butt Barrier by

Drug Labeling and Warnings

Boudreauxs Butt Barrier 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

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)                  

INGREDIENTS AND APPEARANCE

BOUDREAUXS BUTT BARRIER 
dimethicone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERYL HYDROXYSTEARATE (UNII: UJ6CAW9YNV)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0326-04	1 in 1 CARTON	03/01/2022
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2022

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