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

Purpose

Anticavity

INDICATIONS & USAGE

Use: Aids in the 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

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

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: 58578-1234-2	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)