Label: PRO-DEN RX- sodium fluoride gel

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

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Drug Label Information

Updated February 28, 2019

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  • Description:

    A homecare, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F). Daily use aids in the prevention of dental caries (decay).

  • Active Ingredients:

    Neutral Sodium Fluoride 1.1% w/w (5000 ppm F).

  • Inactive Ingredients:

    Carboxymethyl cellulose sodium, flavor, phosphoric acid, purified water, sodium hydroxide and sucralose.

  • Clinical Pharmacology:

    Applying preparations containing high fluoride concentrations on a regular basis increases the fluoride ion levels in tooth enamel and improves tooth resistance to acid dissolution.

  • Indications and Usage:

    A homecare, self-applied topical fluoride treatment. Aids in the prevention of dental caries (decay).

  • Contraindications:

    Do not use in children under 6 unless recommended by a dentist.

  • Warnings:

    KEEP OUT OF REACH OF CHILDREN. Children under 6 years old: The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.

  • Precautions:

    Limited to topical use in mouth only. DO NOT SWALLOW.

  • Overdosage:

    Swallowing a normal treatment dose (approximately 2 mg of fluoride) is not harmful.

    Store at Room Temperature

  • Dosage and Administration:

    Apply daily at bedtime, in place of your regular toothpaste or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least two minutes. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. Children under 12: Rinse mouth thoroughly immediately after use.

    When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least one minute. Remove applicator and rinse mouth. Clean applicator with cold water.

  • How Supplied:

    Net Wt. 2 oz. (56 g) tube in a box.

    Cool Mint: NDC 59883-824-02

    Reorder 1-800-433-6628

    Reorder Number: 2240MTM 965918

    Manufactured for

    Den-Mat Holdings, LLC

    1017 W. Central Ave.,

    Lompoc, CA 93436

    ©2014 Den-Mat Holdings, LLC.

    All rights reserved.

  • Principal Display Panel - Carton Label

    NDC 59883-824-02

    pro-denRx ®

    aqueous gel

    1.1% neutral sodium fluoride

    cool mint
    flavor

    Contains: 1.1% sodium fluoride
    (5000 ppm fluoride ion) in a
    neutral topical aqueous gel

    Net Wt. 2oz. (56 g)

    DYE-FREE GEL

    Figure
  • Principal Display Panel - Tube Label

    NDC 59883-824-02

    1.1% neutral sodium fluoride

    pro-denRx ® aqueous gel

    cool mint
    flavor

    Contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical aqueous gel

    Net Wt. 2oz. (56 g) DYE-FREE GEL

    Figure
  • INGREDIENTS AND APPEARANCE
    PRO-DEN RX 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59883-824
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.3 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59883-824-021 in 1 CARTON01/20/2009
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/20/2009
    Labeler - Den-mat Holdings, Llc (809857704)
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