Label: NEUTRAGARD GEL MINT- topical neutral fluoride gel gel

  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 30, 2019

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

  • Dosage

    RX Only in USA

    Before dispensing remove cap and peel off seal

    Contains: 1.1% w/w Sodium fluoride (provides 5000ppm fluoride)

    Usual treatment does contains 1-3 mg fluoride. A 2.0oz tube contains 300 mg of fluoride

  • Indications & Usage

    Indications and Usage

    Aids in the prevention of dental cavities. This is an anti-cavity (preventive treatment gel, not a toothpaste. Read directions carefully before using. Clinical studies have shown that 1.1% sodium fluoride is safe and effective as an anti-cavity agent when used topically. This product should be applied with a toothbrush after brushing with a dentifrice toothpaste. It can be used in areas where drinking water is fluoridated since topical fluorides do not produce fluorosis when used as directed.

    Adults and children 6 years of age and older: Use once daily after brushing with a dentifrice toothpaste. Apply a thin ribbon of gel to toothbrush and brush teeth thoroughly. Allow the gel to reamin on your teeth for 1 minute and then spit out. Do not swallow gel. For best effectiveness, do not eat or drink for 30 minutes after brushing. Supervise children less than 12 years of age as necessary when using this product to minimize swallowing.

    Children under 6 years of age - consult a dentist or physician.

  • Contraindications

    Hypersensitivity to fluoride

  • Warnings & Precautions

    Do not swallow.

    Keep this and all drugs out of reach of children.

    For use only under supervision of a dental professional or physician.

    Adverse Reactions: Developing teeth of children under 6 years of age may become permanently discolored if excess quantities are repeatedly swallowed. Reactions of individuals whith fluoride hypersensitivity amy include: eczema, atopic dermatitis, uticaria, gastric distress, headache, and weakness.

    Overdose: If you accidentally swallow more than used for brushing, administer calcium (e.g. milk) and seek professional medical assistance or contact local Poison Control Center immediately.

    For product SDS information, please see company website at or contact Pascal directly.

    Neutragard Gel is free of gluten, milk, soy, egg, peanut and tree nut products.

    Store product between 59-86ºF (15-30ºC)

  • NeutraGard Gel 1.1% Neutral Sodium Fluoride Gel Mint

    NeutraGard Gel Mint TubepH7 5000

    Preventive Treatment Gel for Home Use

    Mint Flavor

    REF 11-715

    topical neutral fluoride gel gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0110
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 942 mg  in 1 g
    Product Characteristics
    FlavorMINTImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10866-0110-160 g in 1 TUBE; Type 0: Not a Combination Product07/01/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only07/01/1999
    Labeler - Pascal Company, Inc. (009260217)
    NameAddressID/FEIBusiness Operations
    Pascal Company, Inc.009260217manufacture(10866-0110)