Label: CLOSYS FLUORIDE RINSE- sodium fluoride rinse
- NDC Code(s): 58578-1234-2
- Packager: Rowpar Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 20, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
- Warning
- KEEP OUT OF REACH OF CHILDREN
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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
- Other Information
- QUESTIONS
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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 FluorideCloSYS 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 soresFOR 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
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INGREDIENTS AND APPEARANCE
CLOSYS FLUORIDE RINSE
sodium fluoride rinseProduct 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)
