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

  • NDC Code(s): 64778-0446-1, 64778-0446-3
  • Packager: AMD Medicom
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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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
    Mint

    1.9 L / 64 fl oz

    NDC 64778-0446-1

    NPN 80008542



    Item code 10044-M

  • 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

  • Non-Medicinal Ingredients

    Citric acid, potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint 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

    Rx Only in US


    Made in USA for AMD Medicom Inc.
    2555 Chemin de l’Aviation,
    Pointe-Claire, 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
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0446
    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
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64778-0446-312 in 1 CASE12/01/2017
    1NDC:64778-0446-11900 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 other03/01/2001
    Labeler - AMD Medicom (256880576)
    Registrant - AMD Medicom (256880576)
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