CLOSYS FLUORIDE RINSE- sodium fluoride rinse 
Rowpar Pharmaceuticals, Inc.

----------

ClōSYS® Silver® ANTICAVITY FLUORIDE RINSE

Drug Facts

ACTIVE INGREDIENT

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

PURPOSE

Anticavity

USE:

Aids in the prevention of dental cavities

WARNING:

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. 

DIRECTIONS: Adults and children 6 years of age and older:

Use once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit out · do not swallow the rinse · do not eat or drink for 30 minutes after rinsing • instruct children under 12 years of age in good rinsing habits (to minimize swallowing) · supervise children as necessary until capable of using without supervision ·
Children under 6 years of age: consult a dentist or doctor.

OTHER INFORMATION:

Do not use if safety seal is broken or missing

INACTIVE INGREDIENTS:

water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose

Questions or comments? Call 1-800-643-3337

Packaging

473ml Inner Label

473 mL Bottle Label

473 mL Carton

Carton Label

100 ml Label

100 mL Bottle Label
CLOSYS  FLUORIDE RINSE
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-1234
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PEPPERMINT (UNII: V95R5KMY2B)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58578-1234-11 in 1 BOX02/18/2016
1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58578-1234-2100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/18/2016
Labeler - Rowpar Pharmaceuticals, Inc. (783704661)

Revised: 12/2023
Document Id: 7d0332cd-7e4a-4bd9-ab32-8ca98a2d6e2b
Set id: 1a994f24-99ee-4b27-aab0-e816931a22c8
Version: 6
Effective Time: 20231222
 
Rowpar Pharmaceuticals, Inc.