Label: BURKHART NEUTRAL- sodium fluoride gel

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

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Drug Label Information

Updated February 11, 2019

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  • Active Ingredient:

    1.1% Sodium Fluoride.

  • Purpose:

    Aids in prevention of dental caries and hypersensitivity. Use as directed by your dentist.

  • Warnings:

    Do not swallow. To avoid ingestion, supervision is required while children are using the product. Keep out of reach of children.

  • Directions:

    Adults and children 6 years of age and older:

    • Twist off cap to remove foil seal.
    • Use once daily after brushing teeth thoroughly with toothpaste.
    • Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces for at least 1 minute.
    • Expectorate, do not swallow, do not eat, drink or rinse for at least 30 minutes.

    Children under 6 years of age:

    • Consult a dentist or physcian.
  • STORAGE AND HANDLING

    Store at controlled room temperature 59° - 86°F (15° - 30°C).

  • Inactive Ingredients:

    Calcium Caseinate, Citric Acid, Flavor, Glycerine, Glydant, Sodium Benzoate, Sodium Hexameta Phosphate, Sodium Saccharine, TriCalcium Phosphate, Vitamin E, Water, Xanthan Gum, Xylitol.

  • PRINCIPAL DISPLAY PANEL

    NeutralGelCherry

  • PRINCIPAL DISPLAY PANEL

    NeutralGelBox

  • INGREDIENTS AND APPEARANCE
    BURKHART NEUTRAL 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43498-301
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.597 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    CASEIN (UNII: 48268V50D5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43498-301-04120 g in 1 TUBE; Type 0: Not a Combination Product02/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/11/2019
    Labeler - Burkhart Dental Supply Inc (027532357)
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