BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse

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

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Active ingredient:
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)
Available from:
Discus Dental, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antibacterial, antiplaque, antigingivitis Helps prevent plaque that leads to gingivitis Helps fight odor-causing bacteria
Authorization status:
OTC monograph not final
Authorization number:
64854-014-11, 64854-014-12, 64854-014-13, 64854-014-14

BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse

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.

----------

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

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

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

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

BREATHRX WITH ZYTEX

cetylpyridinium chloride rinse

Product Information

Product T ype

HUMAN OTC DRUG

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

XYLITO L (UNII: VCQ0 0 6 KQ1E)

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

MINT (UNII: FV9 8 Z8 GITP)

THYMO L (UNII: 3J50 XA376 E)

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

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

WATER (UNII: 0 59 QF0 KO0 R)

ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z)

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

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

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

0 7/21/20 0 6

2

NDC:6 48 54-0 14-

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

Pro duc t

0 7/21/20 0 6

3

NDC:6 48 54-0 14-

9 76 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/21/20 0 6

4

NDC:6 48 54-0 14-

378 5 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/21/20 0 6

Discus Dental, LLC

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

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 14)

Revised: 11/2018

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