FDA Label for Closys Silver Healthy Gums

View Indications, Usage & Precautions

Closys Silver Healthy Gums Product Label

The following document was submitted to the FDA by the labeler of this product Rowpar Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Active ingredientPurpose
Cetylpyridinium chloride 0.075Antigingivitis/Antiplaque

Uses



  • Helps prevent and reduce plaque and gingivitis.
  • Helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums.

Warnings



Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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.


Dosage & Administration



Directions
Adults and children
12 years and over
Vigorously swish 20 milliliters of rinse
between your teeth for 30 seconds and
then spit out. Do not swallow rinse.
Children 6 years to
under 12 years
Supervise use.
Children under
6 years
Do not use.

Other Information



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

Inactive Ingredient



Inactive ingredients water, potassium sorbate, trisodium phosphate, citric acid, sodium benzoate, mint flavor, sucralose, benzoic acid


Questions Or Comments?



call 1-800-643-3337


Package Label.Principal Display Panel



Non-Burning, Non-Irritating Formula

NEW!

A CLEANER MOUTH
A HEALTHIER YOU®

ClōSYS®
Antigingivitis/Antiplaque Mouth Rinse

HEALTHY
GUMS


SENSITIVE
MOUTH RINSE


KILLS GERMS
THAT CAUSE GINGIVITIS, PLAQUE
& BAD BREATH

Helps Reverse Early Signs
of Gum Disease

Freshens Breath

Non Burning, Alcohol Free

Gentle Mint

32 fl oz (946 mL)

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 Founder of CloSYS® Oral Care.

What Makes CloSYS®
Products 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.

How Does CloSYS®
Healthy Gums Work?

CloSYS® Healthy Gums Oral Rinse kills germs that
cause gingivitis, plaque and bad breath and helps
reverse early signs of gum disease (redness,
bleeding and inflammation).

Its gentle formula protects against plaque formation
that oftens leads to gingivitis, while the gentle mint
flavor freshens breath. And, the formula doesn’t
contain alcohol, sulfates, triclosan, and other
ingredients that can burn or irritate the mouth or
gums so you can rinse longer and get great results!

HEALTHY Mouth= HEALTHY Body
Gentlest.
Oral Care.
Ever.®

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

This bottle is recyclable. Please
support recycling in your community.

55032-39

A CLEANER MOUTH
A HEALTHIER YOU®

ClōSYS
Antigingivitis/Antiplaque Mouth Rinse

HEALTHY
GUMS


SENSITIVE
MOUTH RINSE


KILLS GERMS
THAT CAUSE GINGIVITIS, PLAQUE
& BAD BREATH

Helps Reverse Early Signs
of Gum Disease

Freshens Breath

Non Burning, Alcohol Free

Gentle Mint

32 fl oz (946 mL)

52532-83

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

This bottle is recyclable. Please
support recycling in your community.

52532-84



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