CloSYS Healthy Gums

Manufacturer
Rowpar Pharmaceuticals, Inc.
Effective date
2026-04-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:52:42

Label at a glance#

ProductCloSYS Silver Healthy Gums
Active ingredientCetylpyridinium Chloride
Label structure9 sections

Indications and 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.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredientPurpose
Cetylpyridinium chloride 0.075Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 - 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.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

Questions or comments?

OTC - QUESTIONS SECTION

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

Carton
Carton

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


Label
Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58578-0407-12024-01-30C16284748780-11030e365-1fc3-111a-e063-dadaa90a10e2CloSYS Healthy Gums Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58578-0407-1CloSYS Silver Healthy Gums1 in 1 CARTONLIQUID15
58578-0407-1CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465
58578-0407-2CloSYS Silver Healthy Gums2 in 1 PACKAGELIQUID25
58578-0407-2CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465
58578-0407-3CloSYS Silver Healthy Gums3 in 1 PACKAGELIQUID35
58578-0407-3CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465
58578-0407-4CloSYS Silver Healthy Gums946 mL in 1 BOTTLELIQUID9465

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58578-040758578-0407-1, 58578-0407-2, 58578-0407-3, 58578-0407-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsExact identifier
ndc (package): 58578-0407-4
ndc (package): 58578-0407-3
ndc (package): 58578-0407-2
ndc (package): 58578-0407-1
ndc (product): 58578-0407
ndc11 (package): 58578040701
ndc11 (package): 58578040702
ndc11 (package): 58578040703
ndc11 (package): 58578040704
spl id: 452e539e-8d6e-4150-832b-c8f6760086eb
spl set id: 11fd3f31-ee0c-43d2-a856-929d1298277c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.