Label: DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE GRAPE- sodium fluoride aerosol, foam

  • NDC Code(s): 64778-0375-1, 64778-0375-3
  • Packager: AMD Medicom Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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 December 9, 2020

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  • General Information

    AMD Medicom Inc.

    DentiCare Pro-Foam

    2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)

    Grape

    4.4 oz / 125 g

    NDC 64778-0375-1

    NPN 80009738

    Rx Only in US

    Item code 10037-GR

  • Indications and Directions

    Indications: topical anti-caries preparation

    Directions:

    1. Following prophylaxis treatment, fill ¼ of tray with foam
    2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
    3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes
    4. Remove tray and have patient expectorate excess

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

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

  • Non-Medicinal Ingredients

    Water, sucralose, sodium phosphate, xylitol, betaine, pluronic, grape flavor

  • Warnings

    KEEP OUT OF REACH OF CHILDREN. For profesional use only

    Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F.

    Contents under pressure. Do not puncture or incinerate.

    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

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  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE GRAPE
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0375
    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 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64778-0375-312 in 1 CASE12/01/201712/31/2021
    1NDC:64778-0375-1125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/200312/31/2021
    Labeler - AMD Medicom Inc. (256880576)
    Registrant - AMD Medicom Inc. (256880576)