Label: BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride kit
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- NDC Code(s): 64854-014-10, 64854-018-04, 64854-032-01
- 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
If you are a consumer or patient please visit this version.
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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.
Do not use if seal is broken.
Warnings
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.
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Toothpaste
Warning
Keep out of reach of children under 6 years of age.
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 older: Brush 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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INGREDIENTS AND APPEARANCE
BREATHRX WITH ZYTEX
cetylpyridinium chloride,sodium fluoride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64854-032 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64854-032-01 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 04/19/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 15 g Part 2 1 BOTTLE, PLASTIC 59 mL Part 1 of 2 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) MICA (UNII: V8A1AW0880) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) MINT (UNII: FV98Z8GITP) THYMOL (UNII: 3J50XA376E) EUCALYPTUS OIL (UNII: 2R04ONI662) 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:64854-018-04 15 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 Part 2 of 2 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 POLOXAMER 407 (UNII: TUF2IVW3M2) MINT (UNII: FV98Z8GITP) THYMOL (UNII: 3J50XA376E) EUCALYPTUS OIL (UNII: 2R04ONI662) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) 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:64854-014-10 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356,part355 04/19/2017 Labeler - Discus Dental, LLC (831726109) Registrant - Discus Dental, LLC (831726109) Establishment Name Address ID/FEI Business Operations Discus Dental, LLC 831726109 manufacture(64854-032)
