Label at a glance#

ProductCloSYS Silver Sensitive Mouth Rinse Fluoride Rinse

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Indications and uses

▪ Aids in the prevention of dental cavities

Dosage and administration

Adults and children 6 years of age and older use twice a day after brushing your teeth with a toothpaste pour out and vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable ...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-643-3337

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

▪ Aids in the prevention of dental cavities

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older

use twice a day after brushing your teeth with a toothpaste
pour out and vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision

Children under 6 years

consult a dentist or doctor

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 ingredients

INACTIVE INGREDIENT SECTION

water, Cloralstan^® (stabilized chlorine dioxide), trisodium phosphate, citric acid, peppermint flavor, sucralose

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-800-643-3337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ClōSYS^®
SILVER^®

Anticavity Fluoride Mouth Rinse

HEALTHY TEETH

SENSITIVE MOUTH RINSE

WITH FLUORIDE
HELPS REBUILD WEAKENED TOOTH
ENAMEL & REVERSE EARLY TOOTH DECAY

Protects Against Cavities

Freshens Breath

Non Burning, Alcohol Free

Gentle pH Balanced

Gentle Mint

32 fl oz (946 mL) 52532-32

Distributed by:
Rowpar Pharmaceuticals, Inc.
Bridgewater, NJ 08807
1 (800) 643-3337 closys.com

This bottle is recyclable. Please
support recycling in your community 52532-33

Non-Burning, Non-Irritating Formula

A CLEANER MOUTH
A HEALTHIER YOU^®

ClōSYS ^®
SILVER ^®

Anticavity Fluoride Mouth Rinse

HEALTHY
TEETH

SENSITIVE
MOUTH RINCE

WITH FLUORIDE

HELPS REBUILD WEAKENED TOOTH
ENAMEL & REVERSE EARLY TOOTH DECAY

Protects Against Cavities

Freshens Breath

Non Burning, Alcohol Free

Gentle pH Balanced

Gentle Mint

32 fl oz (946 mL)

A CLEANER MOUTH
A HEALTHIER YOU^®

ClōSYS ^®
SILVER ^®

Serious Science for Sensitive Mouths ™

How does CloSYS ^® Silver
with Flouride Work?

CloSYS^® Silver Healthy Teeth Mouth Rinse contains fluoride to help protect against cavities. With regular use, it helps rebuild weakened tooth enamel, reverse early tooth decay, and strengthen teeth to improve their appearance. The patented dual action formula contains Cloralstan® which kills bad breath bacteria and neutralizes sulfur mouth odor molecules for long lasting fresh breath. CloSYS® Silver Healthy Teeth Mouth Rinse does not contain alcohol, sulfates, triclosan, and other ingredients that can burn or irritate the mouth so you can rinse longer to get great results!

HEALTHY Mouth = HEALTHY Body

Gentlest.
Oral Care.
Ever.^®

A CLEANER MOUTH
A HEALTHIER YOU^®

ClōSYS ^®
SILVER ^®

Serious Science for Sensitive Mouths ™

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 CloSYS® Oral Care.

What Makes CloSYS ^®
Product 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.

Distributed by:
Rowpar Pharmaceuticals, Inc.
Bridgewater, NJ 08807
1 (800) 643-3337 closys.com

This bottle is recyclable. Please
support recycling in your community

55032-42

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	5
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	5
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	5
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58578-0517-1	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	473 mL in 1 BOTTLE	RINSE	473	5
58578-0517-1	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	1 in 1 BOX	RINSE	1	5
58578-0517-2	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	2 in 1 PACKAGE	RINSE	2	5
58578-0517-2	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	946 mL in 1 BOTTLE	RINSE	946	5
58578-0517-3	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	946 mL in 1 BOTTLE	RINSE	946	5
58578-0517-3	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	3 in 1 PACKAGE	RINSE	3	5
58578-0517-4	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	946 mL in 1 BOTTLE	RINSE	946	5

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse
Sodium Fluoride
FLUORIDE ION
WATER
CHLORINE DIOXIDE
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE
ANHYDROUS CITRIC ACID
PEPPERMINT
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58578-0517	58578-0517-1, 58578-0517-2, 58578-0517-3, 58578-0517-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
CHLORINE DIOXIDE	8061YMS4RM	IACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	B70850QPHR	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
PEPPERMINT	V95R5KMY2B	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	2026-04-01	Warnings	Exact identifier ndc (package): 58578-0517-1 ndc (package): 58578-0517-2 ndc (package): 58578-0517-3 ndc (package): 58578-0517-4 ndc (product): 58578-0517 ndc11 (package): 58578051701 ndc11 (package): 58578051704 ndc11 (package): 58578051703 ndc11 (package): 58578051702 spl id: 5b621757-befa-4ce3-920d-b884aca94420 spl set id: 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796

Reported adverse events (FAERS/openFDA)#

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