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NDC 00132-0194-14 Boudreauxs 40 g/100g Details

Boudreauxs 40 g/100g

Boudreauxs is a TOPICAL PASTE 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	00132-0194
Product ID	0132-0194_15079401-c9d2-49d2-86e4-7cb9b7e5c07d
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	PASTE
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	g/100g
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 00132-0194-14 (00132019414)

Pricing Information	N/A
NDC Package Code	0132-0194-14
Billing NDC	00132019414
Package	397 g in 1 JAR (0132-0194-14)
Marketing Start Date	2016-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 584ccf7d-c355-45eb-bb4f-fd2f154fbd89 Details

Active Ingredient

Zinc Oxide, 40%....Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness

Warning

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 the reaach 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 tempature, 20C to 27C (68F to 80F).
Remove seal from jar before use.
Use with infants, children and adults.
Will stain clothing and fabric.

Inactive Ingredients

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

Questions or Comments

Call 1-855-785-2888 or www.buttpaste.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOUDREAUXS

zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0194
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 g in 100 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	Marketing End Date
Packaging
1	NDC:0132-0194-14	397 g in 1 JAR; Type 0: Not a Combination Product	10/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/01/2016

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

Revised: 12/2016

Document Id: 15079401-c9d2-49d2-86e4-7cb9b7e5c07d

Set id: 584ccf7d-c355-45eb-bb4f-fd2f154fbd89

Version: 3

Effective Time: 20161215