CLOSYS FLUORIDE RINSE- sodium fluoride rinse

CloSYS by

Drug Labeling and Warnings

CloSYS by is a Otc medication manufactured, distributed, or labeled by Rowpar Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

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

Purpose

Anticavity

INDICATIONS & USAGE

Use: Aids in prevention of dental cavities

Warning

KEEP OUT OF REACH OF CHILDREN

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CLOSYS  FLUORIDE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58578-1234
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58578-1234-1	1 in 1 BOX	02/18/2016
1		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58578-1234-2	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/18/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/18/2016

Labeler - Rowpar Pharmaceuticals, Inc. (783704661)