Closys

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.916 mg)

Inactive Ingredients

Water Hydrated Silica Chlorine Dioxide Carboxymethylcellulose Sodium Phosphate, Dibasic, Anhydrous Titanium Dioxide Peppermint Oil Sodium Phosphate, Monobasic, Anhydrous Sodium Myristoyl Sarcosinate Sucralose Menthol, Unspecified Form

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-01-06 Until 2024-01-01

Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.21% (0.11% w/v fluoride ion)

Uses:

aids in the prevention of dental decay

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose:

Anticavity

Packaging

GENTLE MINT

A CLEANER MOUTH

A HEALTHIER YOU^®

CLōSYS^®

SILVER^®

Gentlest. Oral Care. Ever ®

for ADULTS 55+

MULTI-BENEFIT TOOTHPASTE

Anticavity Protection

Remineralizes Enamel

Freshens Breath

Gentle / Non-irritating

ADA Accepted

American Dental Association

3.4 oz

(96g)

ADA Accepted

American Dental Association

Helps prevent cavities

pH balanced

Naturally activated for faster results

Strengthens Enamel

SULFATE-FREE

Dist by:

Rowpar Pharmaceutical, Inc.

Scottsdale, AZ 85260

CloSYS.com

55034-37

MADE IN THE

USA

GENTLE MINT

A CLEANER MOUT

A HEALTHIER YOU^®

CLōSYS ^® SILVER ^®

Gentlest. Oral Care. Ever ®

for ADULTS 55+

MULTI-BENEFIT TOOTHPASTE

Anticavity Protection

Remineralizes Enamel

Freshens Breath

Gentle / Non-irritating

3.4 oz

(96g)

Use of standardized chlorine dioxide is protected under U.S. & foreign patents-see CloSYS.com/patents

ADA Accepted

American Dental Association

Helps prevent cavities

Dist by:

Rowpar Pharmaceutical, Inc.

Scottsdale, AZ 85260

CloSYS.com

MADE IN THE

USA

54534-56

Directions:

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children under 6 years of age:

· instruct in good brushing and rinsing habits (to minimize swallowing).

· supervise children as necessary until capable of using without supervision.

· do not swallow

Children under 2 years of age:

Consult a dentist or doctor

Active Ingredient:

Sodium fluoride 0.21% (0.11% w/v fluoride ion)

Inactive Ingredients:

water, hydrated silica, stabilized chlorine dioxide, cellulose gum, disodium hydrogen phosphate, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sodium myristoyl sarcosinate (coconut derived), sucralose, menthol crystals

Questions Or Comments?

Call 1-800-643-3337

Structured Label Content

Uses: (USES:)

aids in the prevention of dental decay

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose: (PURPOSE:)

Anticavity

Packaging

GENTLE MINT

A CLEANER MOUTH

A HEALTHIER YOU^®

CLōSYS^®

SILVER^®

Gentlest. Oral Care. Ever ®

for ADULTS 55+

MULTI-BENEFIT TOOTHPASTE

Anticavity Protection

Remineralizes Enamel

Freshens Breath

Gentle / Non-irritating

ADA Accepted

American Dental Association

3.4 oz

(96g)

ADA Accepted

American Dental Association

Helps prevent cavities

pH balanced

Naturally activated for faster results

Strengthens Enamel

SULFATE-FREE

Dist by:

Rowpar Pharmaceutical, Inc.

Scottsdale, AZ 85260

CloSYS.com

55034-37

MADE IN THE

USA

GENTLE MINT

A CLEANER MOUT

A HEALTHIER YOU^®

CLōSYS ^® SILVER ^®

Gentlest. Oral Care. Ever ®

for ADULTS 55+

MULTI-BENEFIT TOOTHPASTE

Anticavity Protection

Remineralizes Enamel

Freshens Breath

Gentle / Non-irritating

3.4 oz

(96g)

Use of standardized chlorine dioxide is protected under U.S. & foreign patents-see CloSYS.com/patents

ADA Accepted

American Dental Association

Helps prevent cavities

Dist by:

Rowpar Pharmaceutical, Inc.

Scottsdale, AZ 85260

CloSYS.com

MADE IN THE

USA

54534-56

Directions: (DIRECTIONS:)

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children under 6 years of age:

· instruct in good brushing and rinsing habits (to minimize swallowing).

· supervise children as necessary until capable of using without supervision.

· do not swallow

Children under 2 years of age:

Consult a dentist or doctor

Active Ingredient: (ACTIVE INGREDIENT: )

Sodium fluoride 0.21% (0.11% w/v fluoride ion)

Inactive Ingredients: (INACTIVE INGREDIENTS:)

water, hydrated silica, stabilized chlorine dioxide, cellulose gum, disodium hydrogen phosphate, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sodium myristoyl sarcosinate (coconut derived), sucralose, menthol crystals

Questions Or Comments? (Questions or comments?)

Call 1-800-643-3337

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USES:": "aids in the prevention of dental decay", "50565-1": "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.", "PURPOSE:": "Anticavity", "Packaging": "GENTLE MINT A CLEANER MOUTH A HEALTHIER YOU ® CLōSYS ® SILVER ® Gentlest. Oral Care. Ever ® for ADULTS 55+ MULTI-BENEFIT TOOTHPASTE Anticavity Protection Remineralizes Enamel Freshens Breath Gentle / Non-irritating ADA Accepted American Dental Association 3.4 oz (96g) ADA Accepted American Dental Association Helps prevent cavities pH balanced Naturally activated for faster results Strengthens Enamel SULFATE-FREE Dist by: Rowpar Pharmaceutical, Inc. Scottsdale, AZ 85260 CloSYS.com 55034-37 MADE IN THE USA GENTLE MINT A CLEANER MOUT A HEALTHIER YOU ® CLōSYS ® SILVER ® Gentlest. Oral Care. Ever ® for ADULTS 55+ MULTI-BENEFIT TOOTHPASTE Anticavity Protection Remineralizes Enamel Freshens Breath Gentle / Non-irritating 3.4 oz (96g) Use of standardized chlorine dioxide is protected under U.S. & foreign patents-see CloSYS.com/patents ADA Accepted American Dental Association Helps prevent cavities Dist by: Rowpar Pharmaceutical, Inc. Scottsdale, AZ 85260 CloSYS.com MADE IN THE USA 54534-56", "DIRECTIONS:": "Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: · instruct in good brushing and rinsing habits (to minimize swallowing). · supervise children as necessary until capable of using without supervision. · do not swallow Children under 2 years of age: Consult a dentist or doctor", "ACTIVE INGREDIENT: ": "Sodium fluoride 0.21% (0.11% w/v fluoride ion)", "INACTIVE INGREDIENTS:": "water, hydrated silica, stabilized chlorine dioxide, cellulose gum, disodium hydrogen phosphate, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sodium myristoyl sarcosinate (coconut derived), sucralose, menthol crystals", "Questions or comments?": "Call 1-800-643-3337"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information