BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride

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

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Discus Dental, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
64854-012-01, 64854-014-11, 64854-018-01, 64854-044-01

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.

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Starter Kit

Toothpas te

Active ingredients

Sodium Fluoride 0.243%

Purpos e

Anticavity

Us e

aids in the prevention of dental cavities

Warnings

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

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 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 15° - 30°C (59° - 86°F)

twist off cap and remove foil seal

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

Tongue Spray

Active Ingredient

Cetylpyridinium chloride 0.085%

Purpos e

Antibacterial

Us e

Helps fight odor-causing bacteria

Warnings

Do not use if seal is broken.

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.

Directions

Shake before use

adults and

children 12

years of age

and older

spray 2-3 times on the

back of the tongue and

gently scape with

cleaner

children 6 - 12

years of age

supervise use

children under

6 years

do not use

Other Information

Store at 15°–30°C (59°–86°F)

Inactive Ingredients

Blue 1, Flavor (Peppermint Oil, Thymol and Eucalyptus Oil), PEG-12 Dimethicone, PEG-40

Hydrogenated Castor Oil, Propylene Glycol, Sodium Saccharin, Water, Zinc Gluconate

Mouth Rinse

Active Ingredients

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.

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

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

Other Information

store at 15° - 30°C (59° - 86°F)

this rinse is not intended to replace brushing or flossing

Do not use products if seals are broken or missing.

Package Label

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 44

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 48 54-0 44-0 1 1 in 1 PACKAGE; Type 1: Co nvenience Kit o f Co -Package

0 9 /18 /20 14

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE

112 g

Pa rt 2

1 BOTTLE, PLASTIC

237 mL

Pa rt 3

1 BOTTLE, PLASTIC

59 mL

Part 1 of 3

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

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

MINT (UNII: FV9 8 Z8 GITP)

CARBO XYMETHYLCELLULO SE (UNII: 0 5JZI7B19 X)

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

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

WATER (UNII: 0 59 QF0 KO0 R)

ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

GLYCERIN (UNII: PDC6 A3C0 OX)

MICA (UNII: V8 A1AW0 8 8 0 )

THYMO L (UNII: 3J50 XA376 E)

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

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

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

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

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

XANTHAN GUM (UNII: TTV12P4NEE)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

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 1

112 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

Part 2 of 3

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

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

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

MINT (UNII: FV9 8 Z8 GITP)

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

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

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

WATER (UNII: 0 59 QF0 KO0 R)

ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

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

THYMO L (UNII: 3J50 XA376 E)

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

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-

237 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 3 of 3

BREATHRX WITH ZYTEX

cetylpyridinium chloride spray

Product Information

Ite m Code (Source )

NDC:6 48 54-0 12

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 .8 5 mg

in 1 mL

Inactive Ingredients

Discus Dental, LLC

Ingredient Name

Stre ng th

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

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

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

PEG-12 DIMETHICO NE (UNII: ZEL54N6 W9 5)

WATER (UNII: 0 59 QF0 KO0 R)

ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

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

THYMO L (UNII: 3J50 XA376 E)

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

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 12-

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

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 9 /18 /20 14

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 44)

Revised: 12/2018

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