ZOOBY TURTLE MELON (SODIUM FLUORIDE) AEROSOL, FOAM [YOUNG DENTAL MANUFACTURING CO 1, LLC]

ZOOBY TURTLE MELON (SODIUM FLUORIDE) AEROSOL, FOAM [YOUNG DENTAL MANUFACTURING CO 1, LLC]
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NDC 0273-0394-44
Set ID 1dd2d298-ea9a-44d3-85c2-0c000834e794
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Young Dental Manufacturing Co 1, LLC
Generic Name
Product Class
Product Number
Application Number
  • Description

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

    Distributed By - Denticator Earth City, MO 63045.

    Net Weight - 4.4 OZ (125g)

    RX 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.

  • 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


  • INGREDIENTS AND APPEARANCE
    ZOOBY  TURTLE MELON
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0394
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.72 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0394-44125 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, In002290302manufacture(0273-0394)

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