Label: ZOOBY TURTLE MELON- sodium fluoride aerosol, foam

  • NDC Code(s): 0273-0394-44
  • Packager: Young Dental Manufacturing Co 1, LLC
  • 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 September 26, 2011

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  • Description

    Product Name- ZOOBY, 1.23 % APF Foam (Turtle Melon Flavor)

    Distributed By - Denticator Earth City, MO  63045.

    Net Weight - 4.4 OZ (125g)

    R X Only

    ZOOBY, 1.23 % APF Foam (Turtle Melon Flavor)  contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride.Does not contain chlorofluorocarbon propellant. Gluten free.

  • Indications

    For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments. Close
  • Dosage and Administration

    1. Break protective tab adjacent to trigger.

    2. Shake can thoroughly for at least 15 seconds before each use.

    3. Hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (The foam will expand slightly higher than the fluoride tray.)

    4. Dry tooth surfaces prior to inserting tray(s) in mouth.

    5. Insert tray(s) into patient’s mouth and have them bite down for 1-4 minutes.

    6. Remove tray(s) and have patient expectorate.

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

  • Warnings

    Do not spray toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 59-86º F (15-30º C). Keep from freezing.

    Refer to Material Safety Data Sheet for additional information. For emergencies contact INFOTRAC at 1-800-535-5053

  • Product Label

    Product  Label of 1.23 % APF Foam (Turtle Melon)

    product label turtle melon

    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-0394
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 2.72 g  in 100 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor WATERMELON Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0273-0394-44 125 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/01/2010
    Labeler - Young Dental Manufacturing Co 1, LLC (006309355)