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NDC 00132-0323-44 Boudreauxs 40 g/113g Details

Boudreauxs 40 g/113g

Boudreauxs is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is ZINC OXIDE.

Product Information

NDC	00132-0323
Product ID	0132-0323_506a264b-66b3-4a01-840d-f40fde15cda6
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	g/113g
Substance Name	ZINC OXIDE
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0323-44 (00132032344)

Pricing Information	N/A
NDC Package Code	0132-0323-44
Billing NDC	00132032344
Package	113 g in 1 TUBE (0132-0323-44)
Marketing Start Date	2012-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 59d90652-a471-4f77-a3d5-88aad9dc9e13 Details

SPL UNCLASSIFIED SECTION

BOUDREAUXS- zinc oxide cream

C.B. Fleet Company, Inc.

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.

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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

Stop use and ask a doctor if condition worsens or does not improve after 7 days

Keep out of reach of children

Keep out of reach of children to prevent accidental ingestion

If swallowed, seek medical help or call Poison Control Center immediately

Directions for Use

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 room temperature, 20C to 27C (68F to 80F) Remove foil seal from the tube's tip

Use with infants, children and adults Will stain clothing and fabric

Inactive Ingredients

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, Petrolatum

Questions or Comments

Call toll free 1-855-785-2888 website www.buttpaste.com

PRINCIPAL DISPLAY PANEL

MAX STRENGTH

EXTRA PROTECTION*

BOUDREAUX’S

BUTT PASTE

NET WT. 2 OZ (57 g)

INGREDIENTS AND APPEARANCE

BOUDREAUXS

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0323
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 g in 113 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0132-0323-14	397 g in 1 JAR; Type 0: Not a Combination Product	02/01/2012
2	NDC:0132-0323-22	57 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2012
3	NDC:0132-0323-44	113 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	02/01/2012

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

Revised: 3/2021

Document Id: 506a264b-66b3-4a01-840d-f40fde15cda6

Set id: 59d90652-a471-4f77-a3d5-88aad9dc9e13

Version: 8

Effective Time: 20210301