NDC 58578-0407 Closys Silver Healthy Gums
Cetylpyridinium Chloride Liquid Oral

Product Information

What is NDC 58578-0407?

The NDC code 58578-0407 is assigned by the FDA to the product Closys Silver Healthy Gums which is a human over the counter drug product labeled by Rowpar Pharmaceuticals, Inc.. The generic name of Closys Silver Healthy Gums is cetylpyridinium chloride. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 58578-0407-1 1 bottle in 1 carton / 946 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code58578-0407
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Closys Silver Healthy Gums
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Cetylpyridinium Chloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Rowpar Pharmaceuticals, Inc.
Labeler Code58578
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		part356
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-15-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Closys Silver Healthy Gums?


Product Characteristics

Flavor(s)MINT (C73404)

Product Packages

NDC Code 58578-0407-1

Package Description: 1 BOTTLE in 1 CARTON / 946 mL in 1 BOTTLE

Product Details

What are Closys Silver Healthy Gums Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CETYLPYRIDINIUM CHLORIDE .75 g/mL - Cationic bactericidal surfactant used as a topical antiseptic for skin, wounds, mucous membranes, instruments, etc.; and also as a component in mouthwash and lozenges.

Closys Silver Healthy Gums Active Ingredients UNII Codes

Closys Silver Healthy Gums Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Closys Silver Healthy Gums Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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

Carton Label - carton

Carton Label - carton

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



* Please review the disclaimer below.