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NDC 00132-0334-44 Boudreauxs 16 g/113g Details

Boudreauxs 16 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	00132-0334
Product ID	0132-0334_1855f24f-5645-4a73-868c-ae1098c1b99d
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	16
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 00132-0334-44 (00132033444)

Pricing Information	N/A
NDC Package Code	0132-0334-44
Billing NDC	00132033444
Package	113 g in 1 TUBE (0132-0334-44)
Marketing Start Date	2012-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 262278f6-7e4c-44ee-b40d-39662a239d73 Details

Active Ingredient

Zinc Oxide, 16%, 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

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor

if condition worsens or does not improve after 7 days

Keep out of the reach of children

Keep out of the 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 prolonged period of time, such as bedtime

Other Information

Store at room temperature, 15C to 30C (59F to 86F)
Remove foil seal from the tube's tip
Use with infants, children and adults

Inactive Ingredients

Aloe Vera, Beeswax, Carnauba Wax, Castor Oil, Citric Acid, Hydrogenated Castor Oil, Peruvian Balsam Oil

Questions or Comments

Phone 1-855-785-2888

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOUDREAUXS

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0334
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
WHITE WAX (UNII: 7G1J5DA97F)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CASTOR OIL (UNII: D5340Y2I9G)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
BALSAM PERU (UNII: 8P5F881OCY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0132-0334-44	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: 10/2017

Document Id: 1855f24f-5645-4a73-868c-ae1098c1b99d

Set id: 262278f6-7e4c-44ee-b40d-39662a239d73

Version: 5

Effective Time: 20171019