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_paste

CLOSYS 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-0729
Route of AdministrationORAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58578-0729-11 in 1 BOX03/15/201110/31/2019
196 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58578-0729-21 in 1 BOX03/15/201110/31/2019
2198 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:58578-0729-31 in 1 BOX03/15/201110/31/2019
321 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/15/201110/31/2019
Labeler - Rowpar Pharmaceuticals, Inc. (783704661)

Revised: 11/2019
Document Id: 9718546e-f86b-0aa7-e053-2995a90a34b6
Set id: 476e9005-3c62-405b-8544-385fbea22fbd
Version: 5
Effective Time: 20191111
 
Rowpar Pharmaceuticals, Inc.