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Fluoridex

Generic Name: stannous fluoride
Dosage Form: oral rinse concentrate

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Fluoridex Stannous Fluoride Oral Rinse Concentrate

Warnings

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

Do not swallow the rinse.

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

Other Information

  • For Professional Office Use Only
  • This product is not intended for home or unsupervised consumer use
  • This product may produce surface staining of the teeth
  • Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • Store at controlled room temperature 15o - 30oC (59o - 86oF)
  • See package insert for additional information

Outer Carton

Bottle label

Fluoridex 
stannous fluoride rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64854-004
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Stannous Fluoride (FLUORIDE ION) FLUORIDE ION .63 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
SPEARMINT OIL  
HYDROGENATED STARCH HYDROLYSATE  
Product Characteristics
Color blue Score     
Shape Size
Flavor MINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 0-7502004865-3 1 BOTTLE, PLASTIC in 1 PACKAGE
1 NDC:64854-004-01 200 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/11/2005
Labeler - Discus Dental, LLC (831726109)
Registrant - Discus Dental, LLC (831726109)
Establishment
Name Address ID/FEI Operations
Discus Dental, LLC 831726109 manufacture(64854-004)
Revised: 04/2015
 
Discus Dental, LLC



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