CloSYS Silver Healthy Gums
CloSYS Healthy Gums
11fd3f31-ee0c-43d2-a856-929d1298277c
HUMAN OTC DRUG LABEL
May 16, 2025
Rowpar Pharmaceuticals, Inc.
DUNS: 783704661
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cetylpyridinium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
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) 643-3337closys.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) 643-3337closys.com
This bottle is recyclable. Please
support recycling in your community.
52532-86
INDICATIONS & USAGE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
WARNINGS SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Active ingredient |
Purpose |
Cetylpyridinium chloride 0.075 |
Antigingivitis/Antiplaque |
OTC - PURPOSE SECTION
DOSAGE & ADMINISTRATION SECTION
Directions | |
Adults and children |
Vigorously swish 20 milliliters of rinse |
Children 6 years to |
Supervise use. |
Children under |
Do not use. |
STORAGE AND HANDLING SECTION
Other Information
- Do not use if safety seal is broken or missing.
- This rinse is not intended to replace brushing or flossing
INACTIVE INGREDIENT SECTION
Inactive ingredients water, potassium sorbate, trisodium phosphate, citric acid, sodium benzoate, mint flavor, sucralose, benzoic acid
OTC - QUESTIONS SECTION
Questions or comments?
call1-800-643-3337