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CloSYS Silver Healthy Gums

CloSYS Healthy Gums

Approved
Approval ID

11fd3f31-ee0c-43d2-a856-929d1298277c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 16, 2025

Manufacturers
FDA

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
NDC Product Code58578-0407
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2025
FDA Product Classification

INGREDIENTS (9)

Cetylpyridinium ChlorideActive
Quantity: 0.75 g in 1 mL
Code: D9OM4SK49P
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Potassium SorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
Sodium Phosphate, Tribasic, DodecahydrateInactive
Code: B70850QPHR
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Sodium BenzoateInactive
Code: OJ245FE5EU
Classification: IACT
MintInactive
Code: FV98Z8GITP
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Benzoic AcidInactive
Code: 8SKN0B0MIM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/26/2023

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

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

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/9/2023

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

LOINC: 50565-1Updated: 2/9/2023

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

LOINC: 34071-1Updated: 2/9/2023

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

LOINC: 55106-9Updated: 2/14/2023

Active ingredient

Active ingredient

Purpose

Cetylpyridinium chloride 0.075

Antigingivitis/Antiplaque

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/9/2023

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/10/2023

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 2/10/2023

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

LOINC: 51727-6Updated: 2/9/2023

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/9/2023

Questions or comments?

call1-800-643-3337

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CloSYS Silver Healthy Gums - FDA Drug Approval Details