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CloSYS Fluoride Rinse by Rowpar Pharmaceuticals, Inc.

Medically reviewed on January 17, 2018

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.05g in 100mL
Labeler: Rowpar Pharmaceuticals, Inc.
NDC Code: 58578-1234

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.

CloSYS® Silver ALCOHOL-FREE Fluoride Rinse

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use: • Aids in 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 teaspoonfuls) 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

Inactive ingredients

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

Other Information
  • do not use if safety seal is broken or missing

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

Best when used with cloSYS Toothpaste 2X a day

Non-Irritating: for Sensitive Mouths

• Alcohol-Free       • Sulfate-Free

• Non-Burning      • Non-Irritating

A Cleaner Mouth. A Healthier You.®

Strengthens Weakened Enamel

Gentle MINT FLAVOR with Fluoride

The cloSYS complete Oral Health System®

Use CloSYS Silver Fluoride Rinse together with CloSYS Fluoride Toothpaste twice a day as directed. Visit CloSYS.com to learn more and discover “A Cleaner Mouth. A Healthier You.®

Oral Care as We Age

Specially Formulated for the changing oral care needs of Adults 55+

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.

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

Your Changing Oral Health

  • Increased sensitivity may happen because as we age the enamel on your teeth can suffer from acid erosion, making your mouth more sensitive to the food and drink we consume.
  • Dry mouth is a common side effect of many prescription and over the counter medications.
  • Painful mouth sores can occur due to sensitivity to sulfates and as side effects from medications including some chemotherapy drugs.

How Does cloSYS Silver Fluoride Rinse Work?

CloSYS recognizes the changing needs of adults and has developed CloSYS Silver specifically to help keep your mouth healthy at any age.CloSYS Silver uses a patented Cloralstan formula naturally activated by the amino acids in your saliva. Once activated CloSYS helps protect your teeth, with fluoride added, to aid in remineralizing enamel without the discomfort often found in other oral care products.


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.

Use of stabilized chlorine dioxide system is protected under patent # 8,926,951 and other U.S. and foreign patents
#1 Best Seller Recommended by Dental Professionals

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

Factory sealed for your protection. Do not use if seal is broken.

IMPORTANT: Read directions for proper use

Please Note: Do not use if the tamper seal is loose, missing, or broken. If spilled on fabric wash out immediately to avoid discoloration of certain fabrics. Although CloSYS is completely safe, swallowing is not recommended.

DISTRIBUTED BY:

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

closys.com

Made in the USA. This bottle is recyclable. Please support recycling in your community.

Packaging

CLOSYS  FLUORIDE RINSE
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-1234
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CHLORINE DIOXIDE 
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE 
ANHYDROUS CITRIC ACID 
PEPPERMINT 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58578-1234-11 BOTTLE in 1 BOX
1473 mL in 1 BOTTLE
2NDC:58578-1234-2100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/18/2016
Labeler - Rowpar Pharmaceuticals, Inc. (783704661)

 
Rowpar Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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