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NDC 00132-0326-04 Boudreauxs Butt Barrier 1 g/113g Details

Boudreauxs Butt Barrier 1 g/113g

Boudreauxs Butt Barrier is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is DIMETHICONE.

Product Information

NDC	00132-0326
Product ID	0132-0326_4cc9575d-b9dc-4da0-bc07-a6618139eafc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Boudreauxs Butt Barrier
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/113g
Substance Name	DIMETHICONE
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0326-04 (00132032604)

Pricing Information	N/A
NDC Package Code	0132-0326-04
Billing NDC	00132032604
Package	1 TUBE in 1 CARTON (0132-0326-04) / 113 g in 1 TUBE
Marketing Start Date	2022-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 06a5af4d-40dd-42a4-8368-4d6a772d1b3a Details

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

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

Ingredient Name	Strength
Inactive Ingredients
.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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/01/2022

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

Revised: 1/2022

Document Id: 4cc9575d-b9dc-4da0-bc07-a6618139eafc

Set id: 06a5af4d-40dd-42a4-8368-4d6a772d1b3a

Version: 1

Effective Time: 20220113