PARODONTAX ACTIVE GUM HEALTH MINT- cetylpyridinium chloride mouthwash PARODONTAX ACTIVE GUM HEALTH CLEAR MINT- cetylpyridinium chloride mouthwash

Parodontax by

Drug Labeling and Warnings

Parodontax by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Cetylpyridinium chloride 0.07% w/w

Purpose

Antigingivitis, Antiplaque

Useshelps prevent and reduce plaque that leads to

• gingivitis, an early form of gum disease
• bleeding gums

Warnings

Stop use and ask a dentist if

• irritation occurs
• 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 the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 6 years of age and older: measure twiceup to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from the bottle.
• children 6 years to under 12 years of age: supervise use
• children under 6 years of age: do not use

Other information

• this rinse is not intended to replace brushing or flossing
• may cause staining
• Do not store above 25°C or 77°F

Inactive ingredients (Mint)

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Inactive Ingredients (Clear Mint)

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid

Questions or comments?

1-855-328-5202

Additional Information

*Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory test

Do not use if the printed seal on the cap is broken or missing.

ALWAYS FOLLOW THE LABEL

Principal Display Panel

NDC: 0135-0651-02

NEW

parodontax

CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
ANTIPLAQUE MOUTHRINSE

ACTIVE GUM HEALTH
DAILY MOUTHWASH

TARGETS BACTERIA*
& FORMS AN
ANTIBACTERIAL SHIELD

MINT

KILLS 99.9%
PLAQUE
BACTERIA*

16.9 FL OZ (500 mL)

L0020006FA: Front Label

L0020006BA: Back Label

Principal Display Panel

NDC: 0135-0650-01

NEW

parodontax

CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
ANTIPLAQUE MOUTHRINSE

ACTIVE GUM HEALTH

DAILY MOUTHWASH

TARGETS BACTERIA*
& FORMS AN
ANTIBACTERIAL SHIELD

CLEAR MINT

DYE FREE
ALCOHOL FREE

16.9 FL OZ (500 mL)

L0020007FA: Front Label

L0020007BA: Back Label

INGREDIENTS AND APPEARANCE

PARODONTAX  ACTIVE GUM HEALTH MINT
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0651
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 188 (UNII: LQA7B6G8JG)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
2,3'-IMINODI-BENZOIC ACID (UNII: H1C37ZB0P3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0651-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2022
2	NDC: 0135-0651-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/03/2022

PARODONTAX  ACTIVE GUM HEALTH CLEAR MINT
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0650
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 188 (UNII: LQA7B6G8JG)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0650-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/03/2022

Labeler - Haleon US Holdings LLC (079944263)