Your browser does not support JavaScript! BOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]
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BOUDREAUXS (zinc oxide) cream
[C.B. Fleet Company, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0323
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE40 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
MINERAL OIL 
PARAFFIN 
BALSAM PERU 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:0132-0323-44113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34702/01/2012
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 01/2013
Document Id: 39e0c859-ccc3-4761-a2d9-61099c6bafde
Set id: 59d90652-a471-4f77-a3d5-88aad9dc9e13
Version: 5
Effective Time: 20130123
 
C.B. Fleet Company, Inc.

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