Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 32b632bf-058d-447b-a7fb-a9dd05c1e2b8
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
Glycerin Poloxamer 407 Benzoic Acid Sodium Benzoate Sucralose Zinc Lactate Saccharin Sodium Fd&c Green No. 3 Fd&c Yellow No. 6 Cinnamaldehyde

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-02

Description

Cetylpyridinium chloride 0.07% w/w

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Cetylpyridinium chloride 0.07% w/w

Uses

helps prevent and reduce plaque that leads to

■ gingivitis, an early form of gum disease

■ bleeding gums

Purposes

Antigingivitis, Antiplaque

Directions

adults and children 6 years of age and older: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 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

Additional Information

parodontax

ACTIVE GUMHEALTH

BREATH FRESHENER

With Breath Cleanse Technology that is designed to kill bacteria that cause bad breath.

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

HELPS PREVENT BLEEDING GUMS

& BAD BREATH BACTERIA

BREATH CLEANSE TECHNOLOGY

BREATH FRESHENER

KILLS 99.9%

PLAQUE BACTERIA*

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

216841

L0021380FC

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.


Structured Label Content

Uses

helps prevent and reduce plaque that leads to

■ gingivitis, an early form of gum disease

■ bleeding gums

Purposes

Antigingivitis, Antiplaque

Directions

adults and children 6 years of age and older: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 product is not intended to replace brushing or flossing

■ may cause staining

■ do not store above 25°C (77°F)

Inactive Ingredients (Inactive ingredients)

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

Additional Information (Additional information)

parodontax

ACTIVE GUMHEALTH

BREATH FRESHENER

With Breath Cleanse Technology that is designed to kill bacteria that cause bad breath.

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

HELPS PREVENT BLEEDING GUMS

& BAD BREATH BACTERIA

BREATH CLEANSE TECHNOLOGY

BREATH FRESHENER

KILLS 99.9%

PLAQUE BACTERIA*

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

216841

L0021380FC

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.

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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