BOUDREAUXS- zinc oxide cream

Boudreauxs by

Drug Labeling and Warnings

Boudreauxs by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide, 16%, Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Protests chafed skin due to diapter 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 immediately

Directions for Use

• Change wet and soiled diapers 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, 15C to 30C (59F to 86F)
• Remove foil seal from the tube's tip or from jar
• 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

Phone 1-855-785-2888 website www.buttpaste.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOUDREAUXS 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0333
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0333-44	113 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2012
2	NDC: 0132-0333-22	57 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2012
3	NDC: 0132-0333-16	454 g in 1 JAR; Type 0: Not a Combination Product	02/01/2012

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

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