ORAL-B FLUORINSE MINT- oral-b fluorinse mint mouthwash 
Oral-B Laboratories

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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Package.Label Principal Display Panel

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

Image of Label

ORAL-B FLUORINSE MINT 
oral-b fluorinse mint mouthwash
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0041-0350
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorblue (Blue 1) , yellow (Yellow 10) Score    
ShapeSize
FlavorSPEARMINT (Spearmint oil) , MENTHOL (Menthol) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0041-0350-07500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/200008/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/04/200008/31/2014
Labeler - Oral-B Laboratories (183102243)

Revised: 8/2017
 
Oral-B Laboratories