FDA.reportPublic FDA data

CloSYS

Manufacturer
Rowpar Pharmaceuticals, Inc.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:52:24

Label at a glance#

ProductCloSYS
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

aids in the prevention of dental decay

Dosage and administration

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). · supervise children as necessary until capable of using without supervision. · do not swallow Children under 2 years of age: Consult a dentist or doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT: 

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSE:

OTC - PURPOSE SECTION

Anticavity

USES:

INDICATIONS & USAGE SECTION

aids in the prevention of dental decay

WARNINGS:

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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).
· supervise children as necessary until capable of using without supervision.
· do not swallow
Children under 2 years of age:
Consult a dentist or doctor

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-800-643-3337

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENTLE MINT

A CLEANER MOUTH
A HEALTHIER YOU® 

CLōSYS®
SILVER®
Gentlest. Oral Care. Ever ®

for ADULTS 55+
MULTI-BENEFIT TOOTHPASTE

Anticavity Protection
Remineralizes Enamel
Freshens Breath
Gentle / Non-irritating

ADA Accepted
American Dental Association

3.4 oz
(96g)


ADA Accepted
American Dental Association
Helps prevent cavities

pH balanced

Naturally activated for faster results

Strengthens Enamel

SULFATE-FREE

Dist by:
Rowpar Pharmaceutical, Inc.
Scottsdale, AZ 85260
CloSYS.com

55034-37

MADE IN THE
USA


Carton Label
Carton Label

GENTLE MINT

A CLEANER MOUT
A HEALTHIER YOU®

CLōSYS® SILVER®
Gentlest. Oral Care. Ever®

for ADULTS 55+
MULTI-BENEFIT TOOTHPASTE

Anticavity Protection
Remineralizes Enamel
Freshens Breath
Gentle / Non-irritating

3.4 oz
(96g)

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

ADA Accepted
American Dental Association

Helps prevent cavities

Dist by:
Rowpar Pharmaceutical, Inc.
Scottsdale, AZ 85260
CloSYS.com

MADE IN THE
USA

 54534-56

Tube Label
Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099038sodium fluoride 0.21 % ToothpastePSN7
1099038sodium fluoride 0.0021 MG/MG ToothpasteSCD7
1099038sodium fluoride 0.21 % ToothpasteSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58578-0759-1CloSYS1 in 1 BOXPASTE, DENTIFRICE17
58578-0759-1CloSYS96 g in 1 TUBEPASTE, DENTIFRICE967
58578-0759-2CloSYS21 g in 1 TUBEPASTE, DENTIFRICE217
58578-0759-2CloSYS1 in 1 BOXPASTE, DENTIFRICE17
58578-0759-3CloSYS2 in 1 PACKAGEPASTE, DENTIFRICE27
58578-0759-3CloSYS96 g in 1 TUBEPASTE, DENTIFRICE967

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58578-075958578-0759-1, 58578-0759-2, 58578-0759-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CHLORINE DIOXIDE8061YMS4RMIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
SODIUM MYRISTOYL SARCOSINATEJ07237209DIACT
SUCRALOSE96K6UQ3ZD4IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
ndc (package): 58578-0759-3
ndc (package): 58578-0759-2
ndc (package): 58578-0759-1
ndc (product): 58578-0759
ndc11 (package): 58578075901
ndc11 (package): 58578075903
ndc11 (package): 58578075902
spl id: ea159a8d-4d2b-49ec-b6e6-f088312c0117
spl set id: ed617c7a-805c-4788-9bce-9b7fead4312d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.