CloSYS Silver Sensitive Mouth Rinse
ClōSYS Silver Anticavity Fluoride Rinse
98a8cee8-9f3c-4a4a-89f8-72e1f1b06796
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.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
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
INDICATIONS & USAGE SECTION
Uses
**▪**Aids in the prevention of dental cavities
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Sodium fluoride 0.02% (0.01% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose
Anticavity
WARNINGS SECTION
Warnings
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 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
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, Cloralstan® (stabilized chlorine dioxide), trisodium phosphate, citric acid, peppermint flavor, sucralose
OTC - QUESTIONS SECTION
Questions or comments?
Call1-800-643-3337