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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Active Ingredient

Zinc Oxide, 40%........Skin Protectant

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

Warnings

Keep out of the reach of children

Warnings

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

Inactive Ingredients

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

Uses

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

Other Information

Store at room temperature, 20C to 27C (68F to 80F)
Use with infants, children and adults
Will stain clothing and fabric

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

Questions?

Call toll free 1-855-785-2888

image of label

BOUDREAUXS
zinc oxide cream

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

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

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL
MINERAL OIL
PARAFFIN
BALSAM PERU
PETROLATUM

Packaging
#	Item Code	Package Description
1	NDC:0132-0323-44	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	02/01/2012

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