Label: ALPHA-PRO- sodium fluoride and hydrofluoric acid gel

  • NDC Code(s): 55346-0942-1
  • Packager: Dental Technologies, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 11, 2017

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  • Indications and Usage:

    Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

  • Contraindications:

    Hypersensitivity to fluoride.

  • 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. Contains FD&C Red No. 40.

  • 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. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

  • 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 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 Fluoirde) in 0.1 Molar Phosphoric Acid.

    DENTAL TECHNOLOGIES

    LINCOLNWOOD, ILLINOIS 60712 USA

    www.dentaltech.com

    Questions or Comments?

    Call: 1-800-835-0885 (US) or 1-847-677-5500

    PM-5097 Rev002

  • Principal Display Panel

    DENTAL TECHNOLOGIES

    www.dentaltech.com

    ALPHA-PRO® APF

    TOPICAL GEL

    60 SECOND TREATMENT

    Acidulated Phosphate Fluoride

    1.23% Fluoride Ion

    Rx Only

    Strawberry

    REF No. 009-4201-002

    NET WEIGHT: 17.5 oz. (497g)

    APF_Strawberry

  • INGREDIENTS AND APPEARANCE
    ALPHA-PRO 
    sodium fluoride and hydrofluoric acid gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55346-0942
    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
    FlavorSTRAWBERRY (Strawberry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55346-0942-1497 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2013
    Labeler - Dental Technologies, Inc. (148312838)
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