Fluoride Dental Treatment Rinse

Manufacturer
DR Products
Effective date
2023-04-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:32:57

Label at a glance#

ProductFluoride Dental Treatment Rinse
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

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 0.7 ppm fluoride ion, then no fluoride supplement is needed. Do not eat or drink for 30 minutes after ri...

Storage and handling

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

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Prevention of dental caries (decay)

Indication

INDICATIONS & USAGE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warning

WARNINGS SECTION

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

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70737-016-122023-04-17C16284748780-1f386c649-bebd-0266-e053-dadaa90a7c1aXyliflor DR products
70737-016-122023-01-30C16284748780-1f386c649-bebd-0266-e053-dadaa90a7c1aXyliflor DR products

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70737-01670737-016-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f98cf0cc-78ce-ca72-e053-6394a90a0be6cff8de8b-9074-8179-e053-2a95a90a29072023-04-17WarningsExact identifier
spl id: f98cf0cc-78ce-ca72-e053-6394a90a0be6
spl set id: cff8de8b-9074-8179-e053-2a95a90a2907

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.