Fluoride Dental Treatment Rinse by DR Products Xyliflor DR products

Fluoride Dental Treatment Rinse by

Drug Labeling and Warnings

Fluoride Dental Treatment Rinse by is a Otc medication manufactured, distributed, or labeled by DR Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLUORIDE DENTAL TREATMENT RINSE- sodium fluoride liquid 
DR Products

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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Xyliflor DR products

Purpose

Prevention of dental caries (decay)

Indication

Xyliflor Fluoride Dental Treatment Rinse is a specially formulated fluoride supplement that is administered by health professionals to aid in the prevention of dental caries (decay) in areas where the water supply contains 0 to 0.7 parts per million (ppm) fluoride ion.

Active Ingredient

Each 10 ml of Xyliflor Fluoride Dental Treatment Rinse contains 0.02% Sodium Fluoride (0.01% Fluoride ion).

Inactive Ingredients

Purified water, Xylitol, Glycerin, natural mint flavor, potassium sorbate, phosphoric acid, hydroxyethylcellulose, sodium phosphate dibasic, sodium hydroxide

Directions

For individuals >16 years of age , clean the teeth and rinse with 10 ml of Xyliflor 0.01% fluoride ion rinse with 5 ml twice daily.

Do not eat or drink for 30 minutes after rinsing.

For children age 3 to 6 years at high risk for tooth decay living in a non-fluoridated community (tap water fluoride concentration <3 parts per million (ppm) fluoride ion), clean the teeth and rinse with 5 mL of Xyliflor 0.01% fluoride ion rinse once daily, then swallow or expectorate per patient preference. If tap water is fluoridated to 0.3 - 0.7 ppm fluoride ion, then reduce dose to 2.5 mL daily. If tap water has >0.7 ppm fluoride ion, then no fluoride supplement is needed. Do not eat or drink for 30 minutes after rinsing.

For children age 6 to 16 years at high risk for tooth decay living in a non-fluoridated community (tap water fluoride concentration <3 parts per million (ppm) fluoride ion), clean the teeth and rinse with 10 mL of Xyliflor 0.01% fluoride ion rinse once daily then swallow or expectorate per patient preference. If tap water is fluoridated to 0.3 - 0.7 ppm fluoride ion, then reduce dose to 5 mL daily. If tap water has >0.7 ppm fluoride ion, then no fluoride supplement is needed. Do not eat or drink for 30 minutes after rinsing.

This product is specially formulated for populations at high risk for tooth decay including special needs and institutionalized populations and can be safely swallowed. This product works best when used in conjunction with a toothbrush or dental swab. Fluoride toothpaste is not recommended to be used in combination with this product in children.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children.

Warning

In case of overdose, get help or contact a Posion Control Center right away.

FOR PROFESSIONAL OFFICE USE ONLY. THIS PRODUCT IS NOT INTENDED FOR HOME OR UNSUPERVISED CONSUMER USE.

Other

Store at room temperature. (20-25°C / 68-77°F)

Label

FLUORIDE DENTAL TREATMENT RINSE 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70737-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SPEARMINT (UNII: J7I2T6IV1N)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
XYLITOL (UNII: VCQ006KQ1E)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70737-016-12473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/19/202109/30/2023
Labeler - DR Products (146752881)

Revised: 4/2023
 

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