Label: SORBET RINSE- sodium fluoride concentrate

  • NDC Code(s): 68400-328-40
  • Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 21, 2022

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  • Active Ingredient (before dilution):

    Fluoride Ion 1.5%

    Available from 3.3% Sodium fluoride.

  • Purpose:

    Anticaries Treatment

  • Indications and Usage:

    • To be used under the direction of or as prescribed by a dental professional.
    • This is a prescription fluoride rinse used to help prevent dental decay.
  • Warnings:

    • Do not use before diluting with water.
    • Keep out of reach of children. Children under 6 years of age: Consult a dentist or doctor prior to use.
    • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help or contact a Poison Control Center right away.
  • Dilution Instructions:

    Use only after properly diluting according to one of the following formulas. Mix with distilled water only.

    A. For 0.2% fluoride ion, neutral pH mouth rinse (weekly treatment):

    Pour entire contents of concentrate bottle (4oz or 113.5mL) into clean mixing quart bottle. Add 28oz (286mL) of distilled water and blend.

    B. For 0.5% fluoride ion, neutral pH mouth rinse (for use as prescribed):

    Pour entire contents of concentrate bottle (4oz or 113.5mL) into clean mixing bottle. Add 8oz (227mL) of distilled water and blend.  

  • Dosage and Administration:

    1. At bedtime, brush and floss teeth thoroughly.

    2. Pour out one tablespoon (1/3oz or 10mL) of the diluted solution.

    3. Place in mouth and rinse for 60 seconds and expectorate (spit out).

    4. Do not eat or drink for 30 minutes.

  • Other Information:

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

  • Inactive Ingredients:

    DMDM Hydantoin, FD&C Blue #1, Flavoring, Polysorbate 20, Saccharin and Water.

  • PRINCIPAL DISPLAY PANEL

    LB.Sorbet Sodium Fluoride_4_OUT.jpg

  • INGREDIENTS AND APPEARANCE
    SORBET RINSE 
    sodium fluoride concentrate
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-328
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1702.5 mg  in 113.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68400-328-40113.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only05/10/2013
    Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc014769301manufacture(68400-328) , label(68400-328)
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