Label: PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel 

  • Label RSS
  • 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

Drug Label Information

Updated 11/12

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

    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 LABEL Item Code (Source) NDC:0273-7006
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 7.9 mg  in 1 g
    HYDROFLUORIC ACID (FLUORIDE ION) 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
    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)
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