Closys Silver Sensitive Mouth Rinse
FDA Label NDC 58578-0517

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rowpar Pharmaceuticals, Inc. for the product Closys Silver Sensitive Mouth Rinse (NDC 58578-0517). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - keep out of reach of children, directions, other information, inactive ingredients, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Purpose

Anticavity

Uses

▪ Aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

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

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

  • 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

Otc - Questions

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

Packaging

A CLEANER MOUTH
A HEALTHIER YOU®

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)                                        52532-30



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

This bottle is recyclable. Please
support recycling in your community         52532-31

Label (Label)

Label (Label)

Non-Burning, Non-Irritating Formula

NEW LOOK!

A CLEANER MOUTH
A HEALTHIER YOU®

ClōSYS®
SILVER®

Anticavity Fluoride Mouth Rinse

HEALTHY
TEETH

HELPS REBUILD
WEAKENED TOOTH ENAMEL & REVERSE
EARLY TOOTH DECAY

Strengthens Teeth & Improves
Their Appearance

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 pH balanced, 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 

55016-19

Carton (Carton)

Carton (Carton)

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