BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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

Summary of Product characteristics

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%
PURPOSE
Antibacterial, antiplaque, antigingivitis
USE
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 TYPE
HUMAN OTC DRUG
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MINT (UNII: FV98Z8GITP)
THYMOL (UNII: 3J50XA376E)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLOXAMER 407 (UNI