Label: BOUDREAUXS BUTT BARRIER- dimethicone ointment
- NDC Code(s): 0132-0326-04
- 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.
Updated January 13, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
BOUDREAUXS BUTT BARRIER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0326 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g in 113 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CASTOR OIL (UNII: D5340Y2I9G) GLYCERYL HYDROXYSTEARATE (UNII: UJ6CAW9YNV) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0326-04 1 in 1 CARTON 03/01/2022 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2022 Labeler - C.B. Fleet Company, Inc. (003119054)