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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CloSYS® Silver ALCOHOL-FREE Fluoride Rinse

Drug Facts

Active ingredient

Sodium fluroide 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:


Children under 6 years of age: consult a dentist or doctor

Inactive ingredients

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

Other Information

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

Specially formulated For Adults 55+

Non-Irritating: for Sensitive Mouths


Alcohol-Free             • Sulfate-Free

• Non-Burning            • Non-Irritating


Gentle MINT FLAVOR with Fluoride

CloSYS SilverTM helps with:

Mild to moderate sensitivity & dry mouth
• Strengthening enamel
• Anticavity protection
• Dentist recommended to help relieve discomfort due to canker sores or chemotherapy sores

FOR YOUR PROTECTION, this bottle has been sealed with an inner cap. DO NOT USE if the seal is broken. For maximum effectiveness, store at room temperature.

Oral Care as We Age

As we age we become more vulnerable to developing chronic diseases. Research points to possible links between adult gum conditions and various diseases like; heart disease, diabetes, stroke, pneumonia, osteoporosis, and more. CloSYS, while not a prevention or cure for these diseases, helps fight the challenges of adult oral conditions.

The CloSYS 100% Satisfaction Guarantee

It’s simple: If you’re not absolutely satisfied for any reason with CloSYS Oral Health Products we’ll refund your purchase in full.

DISTRIBUTED BY:

Rowpar Pharmaceuticals, Inc.
Scottsdale, AZ 85260
1 (800) 643-3337
closys.com

Packaging

closys

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:58578-1234-2100 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 finalpart35502/18/2016
Labeler - Rowpar Pharmaceuticals, Inc. (783704661)

Revised: 2/2016
Document Id: 17c6fe49-c7e6-464a-b35f-c588c2149a5b
Set id: e164f877-3163-4c16-afae-ff83efb079d9
Version: 2
Effective Time: 20160220
 
Rowpar Pharmaceuticals, Inc.