Label: THERABREATH PLAQUE CONTROL- cetylpyridinium chloride rinse
- NDC Code(s): 10237-259-16
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
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 5, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
THERABREATH PLAQUE CONTROL
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-259 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.015 mg in 20 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) POLOXAMER 407 (UNII: TUF2IVW3M2) Sodium Benzoate (UNII: OJ245FE5EU) Sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-259-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 04/25/2023 Labeler - Church & Dwight Co., Inc. (001211952)