Clōsys®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.02 g)

Inactive Ingredients

Water Chlorine Dioxide Sodium Phosphate, Tribasic, Dodecahydrate Anhydrous Citric Acid Peppermint Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-01

Medication Information

Purpose

Anticavity

Description

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

Uses

▪ Aids in the prevention of dental cavities

Section 50565-1

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.

Section 53413-1

Questions or comments?

Call 1-800-643-3337

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

Active Ingredient

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

Other Information

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

Inactive Ingredients

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

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

Structured Label Content

Uses

▪ Aids in the prevention of dental cavities

Section 50565-1 (50565-1)

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.

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-643-3337

Purpose

Anticavity

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

Active Ingredient (Active ingredient)

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

Other Information

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

Inactive Ingredients (Inactive ingredients)

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

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) 643-3337 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

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORINE DIOXIDE", "unii": "8061YMS4RM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE", "unii": "B70850QPHR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "▪ Aids in the prevention of dental cavities", "50565-1": "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.", "53413-1": "Questions or comments? Call 1-800-643-3337", "Purpose": "Anticavity", "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", "Active ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Other Information": "Do not use if safety seal is broken or missing. This rinse is not intended to replace brushing or flossing", "Inactive ingredients": "water, Cloralstan ® (stabilized chlorine dioxide), trisodium phosphate, citric acid, peppermint flavor, sucralose", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information