Oral-B Fluorinse

Generic Name: sodium fluoride
Dosage Form: mouthwash

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.

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DESCRIPTION: Oral-B Fluorinse is a neutral mint flavored 0.2% sodium fluoride aqueous solution.


ACTIVE INGREDIENT: Sodium Fluoride 0.2% (w/w)

INACTIVE INGREDIENTS: Purified water, Methylparaben, Polysorbate 80, Sodium saccharin, Methyl salicylate, Propylparaben, Sodium hydroxide, Spearmint oil, Menthol, Blue 1, Yellow 10

INDICATION AND USE: A once weekly mouthrinse for the prevention of dental caries.

WARNINGS: DO NOT SWALLOW. Keep out of reach of children. If more than used for rinsing is swallowed, administer calcium (e.g. milk) and get medical help or contact a Poison Center right away.

DOSAGE AND ADMINISTRATION: Adults and pediatric patients over 6 years of age. Use once a week or as directed by your dentist or physician, preferably at bedtime after brushing and flossing teeth thoroughly. Rinse vigorously with 10 ml (2 tsp) around and between the teeth for one minute, then expectorate. DO NOT SWALLOW.

Fluorinse Mint 0.2% Sodium Fluoride

Oral-B Fluorinse MINT 
Oral-B Fluorinse mint mouthwash
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0041-0350
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride ion) Fluoride ion 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Propylparaben  
Product Characteristics
Color blue (Blue 1) , yellow (Yellow 10) Score     
Shape Size
Flavor SPEARMINT (Spearmint oil) , MENTHOL (Menthol) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0041-0350-07 500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/04/2000
Labeler - Oral-B Laboratories (183102243)
Revised: 10/2010
 
Oral-B Laboratories



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