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CloSYS Silver Sensitive Mouth Rinse

ClōSYS Silver Anticavity Fluoride Rinse

Approved
Approval ID

98a8cee8-9f3c-4a4a-89f8-72e1f1b06796

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.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58578-0517
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2025
FDA Product Classification

INGREDIENTS (7)

SODIUM FLUORIDEActive
Quantity: 0.02 g in 100 mL
Code: 8ZYQ1474W7
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CHLORINE DIOXIDEInactive
Code: 8061YMS4RM
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEInactive
Code: B70850QPHR
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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) 643-3337closys.com

This bottle is recyclable. Please
support recycling in your community52532-33

Label

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) 643-3337closys.com

This bottle is recyclable. Please
support recycling in your community

55032-42

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/26/2022

Uses

**▪**Aids in the prevention of dental cavities

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/19/2022

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/16/2022

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/18/2016

Purpose

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 12/16/2022

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/19/2022

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

LOINC: 34068-7Updated: 12/19/2022

Directions

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 12/20/2022

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: 12/16/2022

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/19/2022

Questions or comments?
Call1-800-643-3337

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