Label: DENTICARE PRO-GEL NEUTRAL SODIUM FLUORIDE- sodium fluoride gel

  • NDC Code(s): 64778-0220-1, 64778-0220-3
  • Packager: AMD Medicom Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 27, 2021

If you are a consumer or patient please visit this version.

  • General Information

    AMD Medicom Inc.

    DentiCare Pro-Gel

    1.1% Neutral Sodium Fluoride Gel for Topical Fluoride Applications (0.5% Fluoride Ions)

    Unflavoured / Dye Free

    16.23 fl oz / 480mL

    NDC 64778-0220-1

    NPN 80008841

    RX Only in US

    Item code 10022-UN

  • Indications and Directions

    A topical anti-caries preparation in a pH 7 thixotropic gel base

    In-Office Directions for use:

    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 4 minutes
    4. Remove tray(s) and have patient expectorate excess

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

    Home Care Directions for use:

    1. Use only on the advice of a dentist
    2. Apply a thin layer of gel on a toothbrush and brush for up to 4 minutes.
    3. Expectorate and rinse well. Do not eat or drink for 30 minutes after the application.

    Medicinal ingredients: Fluoride ions 0.5% w/w (from 1.1% w/w neutral sodium fluoride)

  • Non-Medicinal Ingredients

    Purified water, saccharin sodium, hydroxyethyl cellulose, xylitol, phosphoric acid, sodium hydroxyde

  • Warnings

    KEEP OUT OF REACH OF CHILDREN

    Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

    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

    Panel 1

  • INGREDIENTS AND APPEARANCE
    DENTICARE PRO-GEL  NEUTRAL SODIUM FLUORIDE
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0220
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.011 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64778-0220-312 in 1 CASE12/01/2017
    1NDC:64778-0220-1480 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 other12/01/2017
    Labeler - AMD Medicom Inc. (256880576)
    Registrant - AMD Medicom Inc. (256880576)