Label: PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 22, 2018

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  • INDICATIONS AND USAGE:

    Topical application of APF gel is indicated in the prevention of dental caries.

  • Warning:

    Keep out of reach of children. Do not swallow.

    If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Do not use on patients with an allergy to fluoride.


  • Precautions:

    For professional use only. This product is not intended for home or unsupervised consumer use. Repeated use may cause dulling of porcelain and ceramic restorations.

  • Adverse reactions:

    Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. Individuals hypersensitive to fluoride may have an adverse reaction.

  • DOSAGE AND ADMINISTRATION:

    After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.

  • HOW SUPPLIED:

    A thixotropic gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F).

    Do not allow to freeze.

  • ACTIVE INGREDIENTS:

    1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoride) in 0.1 Molar Phosphoric Acid.

    Contains: FD&C Red #40

  • Principal Display Panel

    NDC 0273-7005-16

    ZOOBY®

    PERFECT CHOICE®

    1.23% APF TOPICAL GEL

    GATOR

    GUM™

    60-Second

    Treatment Acidulated

    Phosphate Fluoride

    1.23% Fluroide Ion

    Net Weight: 17.5 oz. (497g)

    GATOR_GUM

  • INGREDIENTS AND APPEARANCE
    PERFECT CHOICE 
    sodium fluoride and hydrofluoric acid gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-7005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.9 mg  in 1 g
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.4 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUM (Gator Gum) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-7005-16497 g in 1 BOTTLE; Type 0: Not a Combination Product12/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/22/2018
    Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
    Registrant - Young Dental Manufacturing Co 1, LLC. (006309355)
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