Label: CLOSYS- sodium fluoride paste, dentifrice
- NDC Code(s): 58578-0759-1, 58578-0759-2
- Packager: Rowpar Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 22, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT:
- PURPOSE:
- USES:
- WARNINGS:
-
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).
· 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:
- Questions or comments?
-
Packaging
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
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
-
INGREDIENTS AND APPEARANCE
CLOSYS
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58578-0759 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.916 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) CHLORINE DIOXIDE (UNII: 8061YMS4RM) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PEPPERMINT OIL (UNII: AV092KU4JH) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D) SUCRALOSE (UNII: 96K6UQ3ZD4) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58578-0759-1 1 in 1 BOX 01/06/2020 1 96 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58578-0759-2 1 in 1 BOX 01/06/2020 2 21 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/06/2020 Labeler - Rowpar Pharmaceuticals, Inc. (783704661)