Label: ORAL-B FLUORINSE MINT - sodium fluoride mouthwash 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 10/10

If you are a consumer or patient please visit this version.

  • DESCRIPTION

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


    ACTIVE INGREDIENT: Sodium Fluoride 0.2% (w/w)
    Close
  • INACTIVE INGREDIENT

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

    Close
  • INDICATIONS & USAGE

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

    Close
  • WARNINGS

    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.

    Close
  • DOSAGE & ADMINISTRATION

    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.

    Close
  • PRINCIPAL DISPLAY PANEL

    Fluorinse Mint 0.2% Sodium Fluoride

    Image of Label

    Close
  • INGREDIENTS AND APPEARANCE
    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 Marketing Start Date Marketing End Date
    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)
    Close