Label: DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY- sodium fluoride liquid

  • NDC Code(s): 64778-0448-1, 64778-0448-3
  • Packager: AMD Medicom Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 27, 2021

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  • General Information

    AMD Medicom Inc.

    DentiCare Pro-Rinse

    2% Neutral Sodium Fluoride Oral Rinse

    Berry

    1.9 L / 64 fl oz

    NDC 64778-0448-1

    NPN 80008542

    Rx Only in US

    Item code 10044-B

  • Indications and Directions


    Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations

    Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional 10mL

    Advise patient not to eat, drink or rinse for 30 minutes after application

    Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls

    Medicinal ingredients: Sodium fluoride 2.0% w/w

  • Non-Medicinal Ingredients

    citric acid, potassium sorbate, purified water, sorbitol, sucralose, red 33, red 40, fruit punch flavour, sodium hydroxide

  • Warnings

    KEEP OUT OF REACH OF CHILDREN. For professional use only

    Not recommended for use by children under 6 years of age. Do not swallow

    Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF

    Do not use if seal is broken

  • Contact Information

    Made in USA for AMD Medicom Inc.
    2555 Chemin de l’Aviation
    Pointe-Claire, Montreal, Quebec, Canada
    H9P 2Z2

    Questions: 1-800-361-2862

    www.medicom.com

  • Principal Display Panel

    DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse

  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-RINSE  NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0448
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 1 mL
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64778-0448-312 in 1 CASE12/01/2017
    1NDC:64778-0448-11900 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2001
    Labeler - AMD Medicom Inc. (256880576)
    Registrant - AMD Medicom Inc. (256880576)
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