Label: ZOOBY GATOR GUM- sodium fluoride aerosol, foam

  • NDC Code(s): 0273-0370-44
  • Packager: Young Dental Manufacturing Co 1, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated January 3, 2023

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  • Description

    Product Name- ZOOBY, 1.23 % APF Foam (Gator Gum Flavor)

    Distributed By - Denticator Earth City, MO 63045.

    Net Weight - 4.4 OZ (125g)

    RX Only

    ZOOBY, 1.23 % APF Foam (Gator Gum 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.

  • 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

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ZOOBY   GATOR GUM
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0370
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.72 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0370-44125 g in 1 CAN; Type 0: Not a Combination Product08/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2010
    Labeler - Young Dental Manufacturing Co 1, LLC (006309355)
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