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, 40%, Skin Protectant

Uses

Warnings

Stop use and ask a doctor

Stop use and ask a doctor if condition worsens or does not improve after 7 days

Keep out of reach of children

Directions for Use

Other Information

Inactive Ingredients

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

Questions or Comments

Call toll free 1-855-785-2888

website www.buttpaste.com

BBP Maximum Strength Carton

BOUDREAUXS 
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0323
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 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:0132-0323-44 113 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2012
2 NDC:0132-0323-22 57 g in 1 TUBE; 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)
Establishment
Name Address ID/FEI Business Operations
Applied Laboratories, Inc. 117337220 manufacture(0132-0323)

Revised: 9/2017
Document Id: f0e2163a-bffa-4a76-878e-4d106222f085
Set id: 59d90652-a471-4f77-a3d5-88aad9dc9e13
Version: 6
Effective Time: 20170915
 
C.B. Fleet Company, Inc.