Label: PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel

  • NDC Code(s): 0273-7006-16
  • Packager: Young Dental Manufacturing Co 1, LLC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • 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 30, 2015

If you are a consumer or patient please visit this version.

  • Indications and Usage:

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

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  • 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.

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  • Precautions:

    For professional use only. Repeated use may cause dulling of porcelain and ceramic restorations.

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  • 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.

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  • 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.

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  • How Supplied:

    A 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.

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  • DESCRIPTION

    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

    Reorder NO. APF 205PS

    TIME TO REORDER! CALL YOUR DENTAL DEALER.

    DISTRIBUTED BY

    BIOTROL

    Earth City, MO 63045

    www.biotrol.com

    Questions or Comments?

    Call: 1-800-822-8550

    12000235A Rev 12/2006

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  • Principal Display Panel

    NDC 0273-7006-16

    ZOOBY perfectchoice®

    One

    Minuteā„¢

    APF Topical Gel

    60 Second Treatment

    Acidulated Phosphate Fluoride

    1.23% Fluroide Ion

    Rx only

    Peppermint
    Stick

    Net Weight: 17.5 oz. (497g)

    image of carton

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  • INGREDIENTS AND APPEARANCE
    PERFECT CHOICE 
    sodium fluoride and hydrofluoric acid gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-7006
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 7.9 mg  in 1 g
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 4.4 mg  in 1 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor PEPPERMINT (Peppermint Stick) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0273-7006-16 497 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/31/2006
    Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
    Registrant - Young Dental Manufacturing Co 1, LLC. (006309355)
    Establishment
    Name Address ID/FEI Business Operations
    Medical Products Laboratories, Inc. 002290302 manufacture(0273-7006)
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