Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 444f931d-5e38-4cda-97ba-98aa0b5fe4f6
Route
ORAL
Published
Effective Date 2025-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (70 mg)
Inactive Ingredients
Water Glycerin Poloxamer 188 Saccharin Sodium Propylene Glycol Sodium Benzoate Sucralose 2,3'-iminodi-benzoic Acid Fd&c Blue No. 1 Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-03

Description

Cetylpyridinium chloride 0.07% w/w

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium chloride 0.07% w/w

Uses
  • gingivitis, an early form of gum disease
  • bleeding gums
Directions
  • 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
Active Ingredient

Cetylpyridinium chloride 0.07% w/w

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

parodontax

ACTIVE GUMHEALTH

Clinically proven ingredient to protect against gum problems

ALWAYS FOLLOW THE LABEL

Do not use if printed safety seal around cap is broken or missing.

*Kills plaque bacteria associated with gingivitis in a laboratory test

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2025 Haleon or Licensor.

Proudly made in the USA with US & globally sourced ingredients. Active made in India.

BOTTLE

RECYCLE

CAP

CHECK LOCALLY

†Recycling facilities for this product may not exist in your area. Cap film not recyclable.

Questions Or Comments?

1-866-844-2797

Principal Display Panel

NEW LOOK

HALEON

DENTIST RECOMMENDED

parodontax

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

ACTIVE GUMHEALTH

DAILY MOUTHWASH

KILLS 99.9% OF & SHIELDS

AGAINST PLAQUE BACTERIA*

MINT

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

216843: Front Label

216846: Back Label

Inactive Ingredients (mint)

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

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.
Inactive Ingredients (clear Mint)

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

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.


Structured Label Content

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

Antigingivitis, Antiplaque

Directions
  • 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
Active Ingredient (Active ingredient)

Cetylpyridinium chloride 0.07% w/w

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
  • may cause staining
  • Do not store above 25°C or 77°F
Additional Information

parodontax

ACTIVE GUMHEALTH

Clinically proven ingredient to protect against gum problems

ALWAYS FOLLOW THE LABEL

Do not use if printed safety seal around cap is broken or missing.

*Kills plaque bacteria associated with gingivitis in a laboratory test

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2025 Haleon or Licensor.

Proudly made in the USA with US & globally sourced ingredients. Active made in India.

BOTTLE

RECYCLE

CAP

CHECK LOCALLY

†Recycling facilities for this product may not exist in your area. Cap film not recyclable.

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

NEW LOOK

HALEON

DENTIST RECOMMENDED

parodontax

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

ACTIVE GUMHEALTH

DAILY MOUTHWASH

KILLS 99.9% OF & SHIELDS

AGAINST PLAQUE BACTERIA*

MINT

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

216843: Front Label

216846: Back Label

Inactive Ingredients (mint) (Inactive ingredients (Mint))

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

Stop Use and Ask A Dentist If (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.
Inactive Ingredients (clear Mint) (Inactive Ingredients (Clear Mint))

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

Keep Out of Reach of Children Under 6 Years of Age. (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.


Advanced Ingredient Data


Raw Label Data

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