Label: DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel

  • NDC Code(s): 64778-0216-1, 64778-0216-3
  • Packager: AMD Medicom Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated January 27, 2021

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  • General Information

    AMD Medicom Inc.

    DentiCare Pro-Gel

    2.72% Topical Sodium Fluoride Gel

    60 Second Application (1.23% fluoride ions)

    Mint

    16.23 fl oz / 480mL

    NDC 64778-0216-1

    NPN 80008336

    RX Only US

    Item code 10021-M

  • Indications and Directions

    Indications: Topical anti-carie preparation

    Directions:

    1. Following prophylaxis treatment, fill 1/3 of tray with gel
    2. Insert tray in the patient's mouth
    3. Have patient bite down lightly for 60 seconds
    4. Remove tray and have patient expectorate excess

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

    Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)

  • Non-Medicinal Ingredients

    Carboxy methyl cellulose sodium, phosphoric acid, water, saccharin sodium, titanium dioxide, blue dye, yellow dye, peppermint oil, spearmint oil

  • Warnings

    KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for use by children under 18 months of age.

    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, Quebec, Canada
    H9P 2Z2

    Questions: 1-800-361-2862

    www.medicom.com

  • Principal Display Panel

    Panel 1

  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0216
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g  in 1 mL
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64778-0216-312 in 1 CASE12/01/2017
    1NDC:64778-0216-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/1999
    Labeler - AMD Medicom Inc. (256880576)
    Registrant - AMD Medicom Inc. (256880576)
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