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

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CloSYS Fluoride Toothpaste

ACTIVE INGREDIENT:

Sodium fluoride 0.24% (0.13% w/v fluoride ion)

PURPOSE:

Anticavity

USE:

Aids in the prevention of dental decay.

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:

children under 2 years of age:

consult a dentist or doctor

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

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

Questions or comments?

Call 1-800-643-3337

Principal Display Panel

Closys®
Anticavity Fluoride Toothpaste

SULFATE-FREE

NEW LOOK!

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS ®
Anticavity Fluoride Toothpaste

SENSITIVE
TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING
SULFATE-FREE

HELPS REBUILD WEAKEND
TOOTH ENAMEL

Protects Against
Cavities

Freshens Breath

Non-Irritating
Formula

Gentle Mint

7oz (196g)

NON-IRRITATING
SULFATE-FREE

pH balanced

Fights
Cavities

Strengthens
Enamel

Closys®
Anticavity Fluoride Toothpaste

SENSITIVE TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING SULFATE-FREE

HELPS REBUILD WEAKEND TOOTH ENAMEL

Protects Against Cavities

Freshens Breath

Non-Irritating Formula

Gentle Mint 7oz (196g)

7 carton

Closys®
Anticavity Fluoride Toothpaste

SULFATE-FREE

NEW LOOK!

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS ®
Anticavity Fluoride Toothpaste

SENSITIVE
TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING
SULFATE-FREE

HELPS REBUILD WEAKEND
TOOTH ENAMEL

Protects Against
Cavities

Freshens Breath

Non-Irritating
Formula

Gentle Mint

3.4oz (96g)

NON-IRRITATING
SULFATE-FREE

pH balanced

Fights
Cavities

Strengthens
Enamel

Closys®
Anticavity Fluoride Toothpaste

SENSITIVE TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING SULFATE-FREE

HELPS REBUILD WEAKEND TOOTH ENAMEL

Protects Against Cavities

Freshens Breath

Non-Irritating Formula

Gentle Mint 3.4oz (96g)

3.4 carton
CLOSYS 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-0749
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
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58578-0749-11 in 1 BOX10/20/2017
196 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58578-0749-21 in 1 BOX10/20/2017
2198 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:58578-0749-31 in 1 BOX10/20/201706/30/2025
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 DrugM02110/20/2017
Labeler - Rowpar Pharmaceuticals, Inc. (783704661)
Establishment
NameAddressID/FEIBusiness Operations
Transom Symphony OPCO, LLC117501991manufacture(58578-0749)

Revised: 12/2023
Document Id: 61e8a01e-1781-4d20-8ac6-9b22cd627f2c
Set id: 5f87abb7-0e9d-6369-e053-2a91aa0a2411
Version: 8
Effective Time: 20231222
 
Rowpar Pharmaceuticals, Inc.