PARODONTAX ACTIVE GUM HEALTH DAILY MOUTHWASH BREATH FRESHENER- cetylpyridinium chloride liquid

Parodontax by

Drug Labeling and Warnings

Parodontax by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Cetylpyridinium chloride 0.07% w/w

Purposes

Antigingivitis, Antiplaque

Uses

helps 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 (500 mL)

■ adults and children 6 years of age and older: measure twice up 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

Directions (1000 mL)

■ adults and children 6 years of age and older: vigorously swish 20 milliliters (4 teaspoonfuls) of 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 product is not intended to replace brushing or flossing

■ may cause staining

■ do not store above 25°C (77°F)

Inactive ingredients

water, glycerin, poloxamer 407, flavor, benzoic acid, sodium benzoate, sucralose, zinc lactate, sodium saccharin, green 3, yellow 6, cinnamal

Questions or comments?

1-866-844-2797

Generic Section

ALWAYS FOLLOW THE LABEL
Do not use if printed safety seal around cap is broken or missing.
Pat. Info www.productpats.com

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

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

BOTTLE
RECYCLE

CAP
CHECK LOCALLY

†Recycling facilities for this product may not exist in your area

206167
L0021380BA

Principal Display Panel

NEW

HALEON

parodontax

CETYLPYRIDINIUM CHLORIDE
ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

DAILY MOUTHWASH

HELPS PREVENT
BLEEDING GUMS
& BAD BREATH
BACTERIA

BREATH CLEANSE TECHNOLOGY

BREATH FRESHENER

KILLS 99.9%
PLAQUE BACTERIA*

ALCOHOL FREE

NET WT 16.9 FL OZ (500 mL)

206166
L0021380FA

INGREDIENTS AND APPEARANCE

PARODONTAX  ACTIVE GUM HEALTH DAILY MOUTHWASH BREATH FRESHENER
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0652
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
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ZINC LACTATE (UNII: 2GXR25858Y)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CINNAMALDEHYDE (UNII: SR60A3XG0F)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0652-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2024
2	NDC: 0135-0652-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/02/2024

Labeler - Haleon US Holdings LLC (079944263)