CLOSYS SILVER HEALTHY GUMS- cetylpyridinium chloride liquid

CloSYS Silver Healthy Gums by

Drug Labeling and Warnings

CloSYS Silver Healthy Gums by is a Otc medication manufactured, distributed, or labeled by Rowpar Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

• Active ingredient: Purpose
• Cetylpyridinium chloride 0.075: Antigingivitis/Antiplaque

PURPOSE

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.

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.

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & 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.

Other Information

• Do not use if safety seal is broken or missing.
• This rinse is not intended to replace brushing or flossing

INACTIVE INGREDIENT

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

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

INGREDIENTS AND APPEARANCE

CLOSYS SILVER HEALTHY GUMS 
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58578-0407
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	0.75 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Phosphate, Tribasic, Dodecahydrate (UNII: B70850QPHR)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Sodium Benzoate (UNII: OJ245FE5EU)
Mint (UNII: FV98Z8GITP)
Sucralose (UNII: 96K6UQ3ZD4)
Benzoic Acid (UNII: 8SKN0B0MIM)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58578-0407-1	1 in 1 CARTON	03/15/2023
1		946 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	03/15/2023

Labeler - Rowpar Pharmaceuticals, Inc. (783704661)