FLUORIDEX- stannous fluoride rinse liquid 
DEN-MAT HOLDINGS, LLC

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Fluoridex - 0.63% Stannous Fluoride Rinse

Active ingredient

Stannous Fluoride 0.63% Rinse Concentrate

Purpose

Anticavity

Use

Warnings

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

Do not swallow the rinse

Directions

Adults and children 6 years of age and older:

Children under 6 years of age

Other Information

Inactive Ingredients

Glycerin, Hydrogenated Starch Hydrolysate, Flavor

Questions or comments?

Call: 1-800-752-2564

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.jpg

FLUORIDEX 
stannous fluoride rinse liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59883-004-011 in 1 BOX01/11/2016
1310 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02101/11/2016
Labeler - DEN-MAT HOLDINGS, LLC (809857704)

Revised: 11/2023
Document Id: 0a96438c-733f-8bce-e063-6394a90a0ce7
Set id: 5e81f073-c0ca-aa38-e053-2a91aa0ab37b
Version: 3
Effective Time: 20231120
 
DEN-MAT HOLDINGS, LLC