FDA.reportPublic FDA data

Fluoridex

Manufacturer
DEN-MAT HOLDINGS, LLC
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:35

Label at a glance#

ProductFluoridex
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years of age and older: Do not use before mixing with water Use once a day after brushing your teeth with a toothpaste Separate provided graduated cup from the mixing cap Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate Add warm water to 1 oz. fill line Place the mixing cap onto the filled cap until it snaps closed Shake thoroughly then remove mixing ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.63% Rinse Concentrate

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental cavities

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

WARNINGS SECTION

Do not swallow the rinse

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • Do not use before mixing with water
  • Use once a day after brushing your teeth with a toothpaste
  • Separate provided graduated cup from the mixing cap
  • Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate
  • Add warm water to 1 oz. fill line
  • Place the mixing cap onto the filled cap until it snaps closed
  • Shake thoroughly then remove mixing cap
  • Use immediately after preparing the rinse
  • Vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out
  • Do not swallow the rinse
  • Repeat the procedure with the remaining half of the prepared solution
  • Do not eat or drink for 30 minutes after rinising
  • 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

Other Information

OTHER SAFETY INFORMATION

  • This product may produce surface staining of the teeth
  • Adequatetoothbrushing may prevent these stains which are harmful or permanent and may be removed by your dentist
  • Store at controlled room temperature 15º - 30ºC (59º - 86º F)
  • See package insert for additional information
  • For your protection, do not use if tamper seal on box is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogenated Starch Hydrolysate, Flavor

Questions or comments?

OTC - QUESTIONS SECTION

Call: 1-800-752-2564

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59883-004-01

FLUORIDEX

DAILY

RENEWAL

Prescription-Strength

Dental Decay Prevention

Oral Rinse Concentrate

CLEAN MINT

0.63% Stannous Fluoride

8.4 fl. oz. (248 ml) Rx Only

Fluoridex_Rinse_image.jpgFluoridex_Rinse_image.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-004-01Fluoridex310 g in 1 BOTTLE, PLASTICLIQUID3103
59883-004-01Fluoridex1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-004FLUORIDEX (STANNOUS FLUORIDE RINSE) LIQUID [DEN-MAT HOLDINGS, LLC]3Current NDC, Legacy NDC, 2 package rows20231216_5e81f073-c0ca-aa38-e053-2a91aa0ab37b.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-00459883-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
GLYCERINPDC6A3C0OXIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT

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
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
ndc (package): 59883-004-01
ndc (product): 59883-004
ndc11 (package): 59883000401
spl id: 0a96438c-733f-8bce-e063-6394a90a0ce7
spl set id: 5e81f073-c0ca-aa38-e053-2a91aa0ab37b

Reported adverse events (FAERS/openFDA)#

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