Closys Healthy Gums

Closys Healthy Gums
SPL v4
SPL
SPL Set ID 11fd3f31-ee0c-43d2-a856-929d1298277c
Route
ORAL
Published
Effective Date 2023-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.75 g)
Inactive Ingredients
Water Potassium Sorbate Sodium Phosphate, Tribasic, Dodecahydrate Anhydrous Citric Acid Sodium Benzoate Mint Sucralose Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-15
Description

Active ingredient Purpose Cetylpyridinium chloride 0.075 Antigingivitis/Antiplaque

Medication Information

Dosage and Administration
Directions
Adults and children

12 years and over		 Vigorously swish 20 milliliters of rinse

between your teeth for 30 seconds and

then spit out. Do not swallow rinse.
Children 6 years to

under 12 years		 Supervise use.
Children under

6 years		 Do not use.
Description

Active ingredient Purpose Cetylpyridinium chloride 0.075 Antigingivitis/Antiplaque

Uses
  • Helps prevent and reduce plaque and gingivitis.
  • Helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums.
Section 50565-1

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.

Section 51727-6

Inactive ingredients water, potassium sorbate, trisodium phosphate, citric acid, sodium benzoate, mint flavor, sucralose, benzoic acid

Warnings

Stop use and ask a dentist if

  • 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.
Active Ingredient
Active ingredient Purpose
Cetylpyridinium chloride 0.075 Antigingivitis/Antiplaque
Other Information
  • Do not use if safety seal is broken or missing.
  • This rinse is not intended to replace brushing or flossing
Questions Or Comments?

call 1-800-643-3337

Package Label.principal Display Panel

Non-Burning, Non-Irritating Formula

A CLEANER MOUTH

A HEALTHIER YOU®



ClōSYS®

Antigingivitis/Antiplaque Mouth Rinse



HEALTHY

GUMS



SENSITIVE

MOUTH RINSE



KILLS GERMS

THAT CAUSE GINGIVITIS, PLAQUE

& BAD BREATH



Helps Reverse Early Signs

of Gum Disease



Freshens Breath



Non Burning, Alcohol Free



Gentle Mint



32 fl oz (946 mL)



Our Story



Founder of CloSYS® & Periodontist Dr. Perry Ratcliff

had a bold belief that there had to be a better/gentler

way to help with oral care. Dr. Ratcliff didn’t agree

with the common myth ‘If it hurts, it must be good

for you.’



CloSYS® took a different approach―keep it gentle,

yet effective, and people will use it long enough

to make a difference in their oral health. After

discovering that his first patented formula was not

only extremely gentle but incredibly effective, he

gathered a small group of dental professionals and

business leaders to start their journey toward what

is today Founder of CloSYS® Oral Care.

What Makes CloSYS®

Products Different?



Simply put, CloSYS® is the Gentlest, Oral Care. Ever.®

All CloSYS® formulas are highly effective and

extremely gentle so they are not harsh or irritating to

sensitive mouths. And because it’s so gentle, it

means you can swish it in your mouth longer without

having to spit it out early and risk not getting the full

benefit of the rinse.



CloSYS® products are free of alcohol, sulfates,

triclosan, and other harsh ingredients that can

burn or irritate sensitive mouths.



How Does CloSYS®

Healthy Gums Work?



CloSYS® Healthy Gums Oral Rinse kills germs that

cause gingivitis, plaque and bad breath and helps

reverse early signs of gum disease (redness,

bleeding and inflammation).



Its gentle formula protects against plaque formation

that oftens leads to gingivitis, while the gentle mint

flavor freshens breath. And, the formula doesn’t

contain alcohol, sulfates, triclosan, and other

ingredients that can burn or irritate the mouth or

gums so you can rinse longer and get great results!



HEALTHY Mouth= HEALTHY Body

Gentlest.

Oral Care.

Ever.®

Distributed by:

Rowpar Pharmaceuticals, Inc.

Bridgewater, NJ 08807

1(800) 643-3337 closys.com

This bottle is recyclable. Please

support recycling in your community.

55002-44

A CLEANER MOUTH

A HEALTHIER YOU®



ClōSYS

 Antigingivitis/Antiplaque Mouth Rinse



HEALTHY

GUMS



SENSITIVE

MOUTH RINSE



KILLS GERMS

THAT CAUSE GINGIVITIS, PLAQUE

& BAD BREATH



Helps Reverse Early Signs

of Gum Disease



Freshens Breath



Non Burning, Alcohol Free



Gentle Mint



32 fl oz (946 mL)



52532-85



Distributed by:  Rowpar Pharmaceuticals, Inc.

Bridgewater, NJ 08807

1(800) 643-3337 closys.com



This bottle is recyclable. Please

support recycling in your community.



52532-86





Structured Label Content

Uses
  • Helps prevent and reduce plaque and gingivitis.
  • Helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums.
Dosage and Administration (34068-7)
Directions
Adults and children

12 years and over		 Vigorously swish 20 milliliters of rinse

between your teeth for 30 seconds and

then spit out. Do not swallow rinse.
Children 6 years to

under 12 years		 Supervise use.
Children under

6 years		 Do not use.
Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients water, potassium sorbate, trisodium phosphate, citric acid, sodium benzoate, mint flavor, sucralose, benzoic acid

Warnings

Stop use and ask a dentist if

  • 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.
Active Ingredient (Active ingredient)
Active ingredient Purpose
Cetylpyridinium chloride 0.075 Antigingivitis/Antiplaque
Other Information
  • Do not use if safety seal is broken or missing.
  • This rinse is not intended to replace brushing or flossing
Questions Or Comments? (Questions or comments?)

call 1-800-643-3337

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Non-Burning, Non-Irritating Formula

A CLEANER MOUTH

A HEALTHIER YOU®



ClōSYS®

Antigingivitis/Antiplaque Mouth Rinse



HEALTHY

GUMS



SENSITIVE

MOUTH RINSE



KILLS GERMS

THAT CAUSE GINGIVITIS, PLAQUE

& BAD BREATH



Helps Reverse Early Signs

of Gum Disease



Freshens Breath



Non Burning, Alcohol Free



Gentle Mint



32 fl oz (946 mL)



Our Story



Founder of CloSYS® & Periodontist Dr. Perry Ratcliff

had a bold belief that there had to be a better/gentler

way to help with oral care. Dr. Ratcliff didn’t agree

with the common myth ‘If it hurts, it must be good

for you.’



CloSYS® took a different approach―keep it gentle,

yet effective, and people will use it long enough

to make a difference in their oral health. After

discovering that his first patented formula was not

only extremely gentle but incredibly effective, he

gathered a small group of dental professionals and

business leaders to start their journey toward what

is today Founder of CloSYS® Oral Care.

What Makes CloSYS®

Products Different?



Simply put, CloSYS® is the Gentlest, Oral Care. Ever.®

All CloSYS® formulas are highly effective and

extremely gentle so they are not harsh or irritating to

sensitive mouths. And because it’s so gentle, it

means you can swish it in your mouth longer without

having to spit it out early and risk not getting the full

benefit of the rinse.



CloSYS® products are free of alcohol, sulfates,

triclosan, and other harsh ingredients that can

burn or irritate sensitive mouths.



How Does CloSYS®

Healthy Gums Work?



CloSYS® Healthy Gums Oral Rinse kills germs that

cause gingivitis, plaque and bad breath and helps

reverse early signs of gum disease (redness,

bleeding and inflammation).



Its gentle formula protects against plaque formation

that oftens leads to gingivitis, while the gentle mint

flavor freshens breath. And, the formula doesn’t

contain alcohol, sulfates, triclosan, and other

ingredients that can burn or irritate the mouth or

gums so you can rinse longer and get great results!



HEALTHY Mouth= HEALTHY Body

Gentlest.

Oral Care.

Ever.®

Distributed by:

Rowpar Pharmaceuticals, Inc.

Bridgewater, NJ 08807

1(800) 643-3337 closys.com

This bottle is recyclable. Please

support recycling in your community.

55002-44

A CLEANER MOUTH

A HEALTHIER YOU®



ClōSYS

 Antigingivitis/Antiplaque Mouth Rinse



HEALTHY

GUMS



SENSITIVE

MOUTH RINSE



KILLS GERMS

THAT CAUSE GINGIVITIS, PLAQUE

& BAD BREATH



Helps Reverse Early Signs

of Gum Disease



Freshens Breath



Non Burning, Alcohol Free



Gentle Mint



32 fl oz (946 mL)



52532-85



Distributed by:  Rowpar Pharmaceuticals, Inc.

Bridgewater, NJ 08807

1(800) 643-3337 closys.com



This bottle is recyclable. Please

support recycling in your community.



52532-86





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Source: dailymed · Ingested: 2026-02-15T12:06:09.447547 · Updated: 2026-03-14T23:08:46.104923