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

  • NDC Code(s): 64778-0373-1, 64778-0373-3
  • 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 December 22, 2023

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  • General Information

    AMD Medicom

    DentiCare Pro-Foam

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

    Bubble Gum

    4.4 oz / 125 g

    NDC 64778-0373-1

    NPN 80009738

    Rx Only in US

    Item code 10037-BG

  • 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, bubble gum flavor

  • Warnings

    KEEP OUT OF REACH OF CHILDREN. For professional 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 and 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

    Panel 1

  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE BUBBLE GUM
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0373
    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
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64778-0373-312 in 1 CASE12/01/201705/31/2024
    1NDC:64778-0373-1125 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 other05/01/200305/31/2024
    Labeler - AMD Medicom Inc. (256880576)
    Registrant - AMD Medicom Inc. (256880576)
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