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CloSYS by Rowpar Pharmaceuticals, Inc.

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1g
Labeler: Rowpar Pharmaceuticals, Inc.
NDC Code: 58578-0749

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.

CloSYS Fluoride Toothpaste

Active Ingredient

Sodium fluoride 0.24% (0.13% 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 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, sarkosyl (coconut derived), disodium hydrogen phosphate, cellulose gum, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sucralose, menthol crystals

Questions or comments?

call 1-800-643-3337

Principal Display Panel

NEW LOOK Same Formula

A Cleaner Mouth.

A Healthier You.

CloSYS®

Non-Irritating TOOTHPASTE

Midly Flavored for

SENSITIVE

Mouths

Anticavity Fluoride

Enamal Protection

GENTAL MINT Flavor

NET WT. 7.0 oz (198g)

ADA Accepted

American

Dental

Association

CLOSYS 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-0749
Route of AdministrationORAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE 
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
CARBOXYMETHYLCELLULOSE 
WATER 
TITANIUM DIOXIDE 
HYDRATED SILICA 
CHLORINE DIOXIDE 
PEPPERMINT OIL (PEPPERMINT)  
MENTHOL 
SODIUM LAUROYL SARCOSINATE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58578-0749-11 TUBE in 1 BOX
196 g in 1 TUBE
2NDC:58578-0749-21 TUBE in 1 BOX
2198 g in 1 TUBE
3NDC:58578-0749-31 TUBE in 1 BOX
321 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/20/2017
Labeler - Rowpar Pharmaceuticals, Inc. (783704661)

 
Rowpar Pharmaceuticals, Inc.

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Medically reviewed on Nov 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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