Label: BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride kit
- NDC Code(s): 64854-012-01, 64854-014-11, 64854-018-01, 64854-044-01
- 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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Toothpaste
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Do not swallow rinse. Supervise children as necessary until capable of using without supervision.
Adults and children 2 years of age and olderBrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 years to 6 years Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 2 years of age Consult a dentist or doctor. Inactive ingredients
Blue 1,Cellulose Gum, Flavor (Mint, Thymol and Eucalyptus Oil), Glycerin, Mica & Titanium Dioxide, PEG-12, Silica, Sodium Lauryl Sulfate, Sodium Methyl Cocoyl Taurate, Sodium Saccharin, Sorbitol, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Water, Xanthan Gum, Xylitol, Zinc gluconate
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Tongue Spray
Warnings
Keep out of reach of children under 6 years of age. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. If spray gets into eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.
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Mouth Rinse
Warnings
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Stop use an ask a dentist if: gingivitis, bleeding, or redness persists for more than 2 weeks; you have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Directions
Do not swallow rinse.
Adults and children 12 years of age and older vigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out Children 6 years to under 12 years supervise use Children under 6 years do not use - WARNINGS
- Package Label
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INGREDIENTS AND APPEARANCE
BREATHRX WITH ZYTEX
cetylpyridinium chloride,sodium fluoride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64854-044 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64854-044-01 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 09/18/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 237 mL Part 2 1 BOTTLE, PLASTIC 59 mL Part 3 1 TUBE 112 g Part 1 of 3 BREATHRX WITH ZYTEX
cetylpyridinium chloride rinseProduct Information 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) XYLITOL (UNII: VCQ006KQ1E) SORBITOL (UNII: 506T60A25R) MINT (UNII: FV98Z8GITP) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLOXAMER 407 (UNII: TUF2IVW3M2) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) THYMOL (UNII: 3J50XA376E) 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/21/2006 Part 2 of 3 BREATHRX WITH ZYTEX
cetylpyridinium chloride sprayProduct Information Item Code (Source) NDC:64854-012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.85 mg in 1 mL Inactive Ingredients Ingredient Name Strength PEPPERMINT OIL (UNII: AV092KU4JH) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) WATER (UNII: 059QF0KO0R) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) THYMOL (UNII: 3J50XA376E) EUCALYPTUS OIL (UNII: 2R04ONI662) 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:64854-012-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/21/2006 Part 3 of 3 BREATHRX WITH ZYTEX
sodium fluoride paste, dentifriceProduct Information Item Code (Source) NDC:64854-018 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.43 mg in 1 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XYLITOL (UNII: VCQ006KQ1E) SORBITOL (UNII: 506T60A25R) MINT (UNII: FV98Z8GITP) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) WATER (UNII: 059QF0KO0R) MICA (UNII: V8A1AW0880) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) GLYCERIN (UNII: PDC6A3C0OX) THYMOL (UNII: 3J50XA376E) EUCALYPTUS OIL (UNII: 2R04ONI662) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) Product Characteristics Color blue (Blue with sparkles) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64854-018-01 112 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 part355 11/21/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356,part355 09/18/2014 Labeler - Discus Dental, LLC (831726109) Registrant - Discus Dental, LLC (831726109) Establishment Name Address ID/FEI Business Operations Discus Dental, LLC 831726109 manufacture(64854-044)