Label: BOUDREAUXS RASH KICKING KIT- zinc oxide kit
- NDC Code(s): 0132-0325-01
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 15, 2020
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- Active ingredient
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- Inactive ingredients
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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Questions or comments
1-855-785-2888 www.buttpaste.com
BOUDREAUX’S® BUTT BRUSH
DIAPER CREAM APPLICATOR
BPA FREE SILICONE
Instructions:
Step 1: Apply Butt Paste® on brush head.
Step 2: Gently brush Butt Paste® on baby’s bottom. For best results, apply thick coat to form a protective barrier.
Step 3: Clean after each use with a baby wipe. Brush can be disinfected in boiling water as needed. It is also dishwasher safe.
Suction cup sticks on almost any surface when changing the diaper.
WARNING:
The Boudreaux’s Butt Brush™ is not a toy. Use only as directed. Discontinue use if skin shows signs of sensitivity or irritation towards the Boudreaux’s Butt Brush™. Discard or sterilize the Boudreaux’s Butt Brush™ in boiling water if comes in contact with yeast infected skin or an infectious rash.
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INGREDIENTS AND APPEARANCE
BOUDREAUXS RASH KICKING KIT
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0325 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0325-01 1 in 1 CARTON; Type 0: Not a Combination Product 05/25/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 57 g Part 2 1 TUBE 57 g Part 1 of 2 BOUDREAUXS
zinc oxide pasteProduct Information 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 57 g Inactive Ingredients Ingredient Name Strength BALSAM PERU (UNII: 8P5F881OCY) CASTOR OIL (UNII: D5340Y2I9G) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color WHITE (Beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 57 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 12/02/2019 Part 2 of 2 BOUDREAUXS
zinc oxide pasteProduct Information 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 57 g Inactive Ingredients Ingredient Name Strength BALSAM PERU (UNII: 8P5F881OCY) CASTOR OIL (UNII: D5340Y2I9G) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color WHITE (Beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 57 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 12/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 05/25/2018 Labeler - C.B. Fleet Company, Inc. (003119054)
