CloSYS

Manufacturer: Rowpar Pharmaceuticals, Inc.
Effective date: 2018-04-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 01:00:14

Label at a glance#

ProductCloSYS

Active ingredientSODIUM FLUORIDE

Label structure8 sections

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) children inder 2 years of age: consult a dentist or doctor supervise children as necessary until capable of using without supervision do not swallow

Contacts and useful links#

PhoneLabel contact1-800-643-3337

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

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)

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

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, stabilized chlorine dioxide, cellulose gum, dibasic sodium phosphate, titanium dioxide, flavor, sodium phosphate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-643-3337

Principal Display Panel

PACKAGE LABEL.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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	2
CHLORINE DIOXIDE	INACTIVE INGREDIENT	8061YMS4RM	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	2
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	2
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

CloSYS
Sodium Fluoride
SORBITOL
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
CARBOXYMETHYLCELLULOSE
WATER
TITANIUM DIOXIDE
HYDRATED SILICA
CHLORINE DIOXIDE
FLUORIDE ION
PEPPERMINT OIL
PEPPERMINT
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58578-0729	58578-0729-1, 58578-0729-2, 58578-0729-3

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
Name	UNII	Kind
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
CHLORINE DIOXIDE	8061YMS4RM	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
PEPPERMINT OIL	AV092KU4JH	IACT
MENTHOL	L7T10EIP3A	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 203 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TROCHE / ORAL	28 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, FILM COATED / ORAL	0.01 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	1.1 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	FILM, SOLUBLE / BUCCAL	0.03 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRA-ARTICULAR		36 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SYRUP / ORAL	0.7 mg/1ml		Exact identifier — unii candidate 41 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 41 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, DELAYED RELEASE / ORAL		43 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	DROPS / ORAL	10 mg/1ml		Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	INJECTION / INTRAMUSCULAR	5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	FILM / BUCCAL	0.35 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SUSPENSION / INTRAMUSCULAR		13 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		8 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRASYNOVIAL		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION/ DROPS / OPHTHALMIC	1.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / OPHTHALMIC	1.21 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / OPHTHALMIC	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	LOZENGE / TRANSMUCOSAL		112 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INSERT / INTRAOCULAR	0.01 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / ORAL		120 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, EXTENDED RELEASE / ORAL		210 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	139.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET / ORAL	45 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.2 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SPRAY, METERED / NASAL		7 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9718546e-f86b-0aa7-e053-2995a90a34b6			476e9005-3c62-405b-8544-385fbea22fbd	2019-11-11	Warnings	Exact identifier spl set id: 476e9005-3c62-405b-8544-385fbea22fbd

Reported adverse events (FAERS/openFDA)#

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