BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)
Available from:
Discus Dental, LLC
Administration route:
DENTAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
64854-014-10, 64854-018-04, 64854-032-01

BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride

Discus Dental, LLC

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.

----------

Cosmetic Kit

Mouth Rinse

Active Ingredient

Cetylpyridinium chloride 0.075%

Purpos e

Antibacterial, antiplaque, antigingivitis

Us e

Helps prevent plaque that leads to gingivitis

Helps fight odor-causing bacteria

Warnings

Keep out of reach of children under 6 years of age.

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.

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 of age: do not use

Other information

Store at controlled room temperature 15°–30°C (59°–86°F)

Inactive Ingredients

Blue 1, Citric acid, Cocamidopropyl Betaine, Flavor (Mint, Thymol and Eucalyptus Oil), PEG-40

Hydrogenated Castor oil, Poloxamer 407, Propylene Glycol, Sodium Saccharin, Sorbitol, Water,

Xylitol, Zinc gluconate.

Toothpas te

Active Ingredients

Sodium Fluoride 0.243%

Purpos e

Anticavity

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.

Other Information

Store at controlled room temperature 15° - 30°C (59° - 86°F).

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

Warning

Do not use if seal is not intact.

BREATHRX WITH ZYTEX

cetylpyridinium chloride,sodium fluoride kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 48 54-0 32

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 48 54-0 32-0 1 1 in 1 PACKAGE; Type 1: Co nvenience Kit o f Co -Package

0 4/19 /20 17

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE, PLASTIC

59 mL

Pa rt 2

1 TUBE

15 g

Part 1 of 2

BREATHRX WITH ZYTEX

cetylpyridinium chloride rinse

Product Information

Ite m Code (Source )

NDC:6 48 54-0 14

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P) (CETYLPYRIDINIUM -

UNII:CUB7JI0 JV3)

CETYLPYRIDINIUM

CHLORIDE

0 .75 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

MINT (UNII: FV9 8 Z8 GITP)

THYMO L (UNII: 3J50 XA376 E)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

PEG-4 0 CASTO R O IL (UNII: 4ERD20 76 EF)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO RBITO L (UNII: 50 6 T6 0 A25R)

ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z)

WATER (UNII: 0 59 QF0 KO0 R)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

Product Characteristics

Color

blue (Light Blue)

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 48 54-0 14-

59 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 7/21/20 0 6

Part 2 of 2

BREATHRX WITH ZYTEX

sodium fluoride paste, dentifrice

Product Information

Ite m Code (Source )

NDC:6 48 54-0 18

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

SODIUM FLUORIDE

2.43 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO XYMETHYLCELLULO SE (UNII: 0 5JZI7B19 X)

MINT (UNII: FV9 8 Z8 GITP)

THYMO L (UNII: 3J50 XA376 E)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

GLYCERIN (UNII: PDC6 A3C0 OX)

MICA (UNII: V8 A1AW0 8 8 0 )

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM PYRO PHO SPHATE (UNII: O3528 6 4B8 Z)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

PO LYETHYLENE GLYCO L 6 0 0 (UNII: NL4J9 F21N9 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM METHYL CO CO YL TAURATE (UNII: JVL9 8 CG53G)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Discus Dental, LLC

XANTHAN GUM (UNII: TTV12P4NEE)

ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO TASSIUM PYRO PHO SPHATE (UNII: B9 W40 19 H5G)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

WATER (UNII: 0 59 QF0 KO0 R)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

Product Characteristics

Color

blue (BLUE WITH SPARKLES)

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 48 54-0 18 -0 4

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

11/21/20 0 5

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356 ,pa rt355

0 4/19 /20 17

Labeler -

Discus Dental, LLC (831726109)

Registrant -

Discus Dental, LLC (831726109)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Discus Dental, LLC

8 31726 10 9

ma nufa c ture (6 48 54-0 32)

Revised: 12/2018

Similar products

Search alerts related to this product

View documents history

Share this information