CLOSYS- sodium fluoride paste, dentifrice

CloSYS by

Drug Labeling and Warnings

CloSYS by is a Otc medication manufactured, distributed, or labeled by Rowpar Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

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

Purpose

Anticavity

Uses

aids in the prevention of dental cavities

Warnings

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.

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)
• children under 2 years of age consult a dentist or doctor: supervise children as necessary until capable of using without supervision do not swallow

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

SPL UNCLASSIFIED SECTION

A CLEANER MOUTH
A HEALTHIER YOU®

Formulated for
ADULTS 55+

Promotes mouth health

Remineralizes enamel

Kills 99% of harmful bacteria 

GENTLE MINT

ADA Accepted 

American Dental Association

Helps prevent cavities

pH balanced for a healthier mouth

Naturally activated for faster results

Reduces harmful dental biofilm

SULFATE-FREE

​Dist by:
Rowpar Pharmaceuticals, Inc.
Scottsdale, AZ 85260
closys.com

Packaging

Packaging

INGREDIENTS AND APPEARANCE

CLOSYS 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58578-0759
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.916 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CHLORINE DIOXIDE (UNII: 8061YMS4RM)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58578-0759-1	1 in 1 BOX	01/06/2020
1		96 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58578-0759-2	1 in 1 BOX	01/06/2020
2		21 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/06/2020

Labeler - Rowpar Pharmaceuticals, Inc. (783704661)