Label: BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse
- NDC Code(s): 64854-014-11, 64854-014-12, 64854-014-13, 64854-014-14
- Packager: Discus Dental, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 16, 2022
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INGREDIENTS AND APPEARANCE
BREATHRX WITH ZYTEX
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64854-014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.75 mg in 1 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MINT (UNII: FV98Z8GITP) THYMOL (UNII: 3J50XA376E) EUCALYPTUS OIL (UNII: 2R04ONI662) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLOXAMER 407 (UNII: TUF2IVW3M2) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color blue (Light blue) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64854-014-11 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/21/2006 2 NDC:64854-014-12 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/21/2006 3 NDC:64854-014-13 976 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/21/2006 4 NDC:64854-014-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/21/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/21/2006 Labeler - Discus Dental, LLC (831726109) Registrant - Discus Dental, LLC (831726109) Establishment Name Address ID/FEI Business Operations Discus Dental, LLC 831726109 manufacture(64854-014)