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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Drug Facts

Active Ingredient

Zinc Oxide, 16%, Skin Protectant

Uses

Warnings

  • 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

Other Information

Inactive Ingredients

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

Questions or Comments

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

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BOUDREAUXS 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
BALSAM PERU (UNII: 8P5F881OCY)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0333-44113 g in 1 TUBE; Type 0: Not a Combination Product02/01/2012
2NDC:0132-0333-2257 g in 1 TUBE; Type 0: Not a Combination Product02/01/2012
3NDC:0132-0333-16454 g in 1 JAR; Type 0: Not a Combination Product02/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2012
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 10/2017
Document Id: 343d2ab8-551d-482a-a4f7-0f70b5a1f8ee
Set id: 4c7e832e-55f3-4766-98b7-29b17d741a4b
Version: 5
Effective Time: 20171018
 
C.B. Fleet Company, Inc.