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NDC 00132-0324-04 Boudreauxs 16 g/113g Details

Boudreauxs 16 g/113g

Boudreauxs 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 ZINC OXIDE.

Product Information

NDC	00132-0324
Product ID	0132-0324_797da4de-e86c-4406-b6e0-de5d4530ca77
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	OINTMENT
Route	TOPICAL
Active Ingredient Strength	16
Active Ingredient Units	g/113g
Substance Name	ZINC OXIDE
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0324-04 (00132032404)

Pricing Information	N/A
NDC Package Code	0132-0324-04
Billing NDC	00132032404
Package	1 TUBE in 1 CARTON (0132-0324-04) / 113 g in 1 TUBE
Marketing Start Date	2019-12-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a Details

SPL UNCLASSIFIED SECTION

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 reach of children

If swallowed, seek medical help or call poison control center (1-800-222-1222)

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 15-25⁰ C (59-77⁰ F)
Remove foil seal from tube’s tip before use
For use with infants, children and adults
Will stain clothing and fabric

Inactive ingredients

mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil

Dist by C. B. Fleet Company, Inc.

Tarrytown, NY 10591

A Prestige Consumer Healthcare company

© 2019 Trade dress is owned by C.B. Fleet company Inc.

All rights reserved. Made in USA

PRINCIPAL DISPLAY PANEL

Sensitive Skin

Boudreaux’s® Butt Paste

Diaper rash ointment

Skin protectant (16% zinc oxide)

NET WT. 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

BOUDREAUXS

zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0324
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	16 g in 113 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0132-0324-04	1 in 1 CARTON	12/02/2019
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0132-0324-02	1 in 1 CARTON	12/02/2019
2		57 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:0132-0324-14	396 g in 1 JAR; Type 0: Not a Combination Product	12/02/2019

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

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

Revised: 12/2020

Document Id: 797da4de-e86c-4406-b6e0-de5d4530ca77

Set id: f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a

Version: 2

Effective Time: 20201203