CloSYS - Sulfate Free Anticavity Toothpaste, Gentle Mint

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]

CLOSYS- sodium fluoride paste, dentifrice 
Rowpar Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CloSYS - Sulfate Free Anticavity Toothpaste, Gentle Mint

Active Ingredient

Sodium fluoride 0.24% (0.11% w/v fluoride ion)

Purpose

Anticavity

Use

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 inder 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, sorbitol, stabilized chlorine dioxide, cellulose gum, dibasic sodium phosphate, titanium dioxide, flavor, sodium phosphate, sucralose

Questions or comments?

call 1-800-643-3337

Principal Display Panel

Gentle

MINT

FLAVOR

ADA

ACCEPTED

American

Dental

Association

NET WT.

7.0 oz (198 g)

CloSYS ®

SULFATE-FREE ANTICAVITY TOOTHPASTE

Non-Irritating: for

Sensitive Mouths

A Cleaner Mouth.

A Healthier You.®

CLOSYS 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58578-0729
Route of Administration	ORAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CHLORINE DIOXIDE (UNII: 8061YMS4RM)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHOL (UNII: L7T10EIP3A)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58578-0729-1	1 in 1 BOX	03/15/2011	10/31/2019
1		96 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58578-0729-2	1 in 1 BOX	03/15/2011	10/31/2019
2		198 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 58578-0729-3	1 in 1 BOX	03/15/2011	10/31/2019
3		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	03/15/2011	10/31/2019

Labeler - Rowpar Pharmaceuticals, Inc. (783704661)

Revised: 11/2019

Document Id: 9718546e-f86b-0aa7-e053-2995a90a34b6

34390-5

Set id: 476e9005-3c62-405b-8544-385fbea22fbd

Version: 5

Effective Time: 20191111

 

Rowpar Pharmaceuticals, Inc.