Label: CONTROLRX- sodium fluoride paste, dentifrice 

  • Label RSS
  • NDC Code(s): 48878-3100-2, 48878-3100-6
  • Packager: 3M ESPE Dental Products
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 05/10

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

  • DESCRIPTION:

    ControlRx dentifrice is a prescription formulation for use in the prevention of dental caries. This formulation contains 1.1% sodium fluoride in a neutral pH base and a mild abrasive to help remove dental plaque, debris and stain.

    ACTIVE INGREDIENT: Sodium Fluoride 1.1% w/w.

    INACTIVE INGREDIENTS: Water, Sorbitol, Hydrated Silica, Glycerin, MICRODENT® 2.0% w/w - a patented ULTRAMULSION® of Dimethicone and Poloxamer 407, PEG 12, Flavor, Cellulose Gum, Sodium Lauryl Sulfate, Titanium Dioxide, Sodium Saccharin.

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  • CLINICAL PHARMACOLOGY:

    The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. ControlRx dentifrice provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges, relative to over the counter fluoride products.

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  • INDICATIONS AND USAGE:

    ControlRx dentifrice is indicated for use as part of a professional program for the prevention and control of dental caries. ControlRx dentifrice is applied to the teeth using a toothbrush. ControlRx dentifrice should be used once daily in place of a conventional toothpaste, unless otherwise instructed by a dental professional.

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  • CONTRAINDICATIONS:

    Do not use in children less than 6 years of age unless recommended by a dental professional.

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  • WARNINGS:

    Do not swallow. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6 ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.

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  • ADVERSE REACTIONS:

    Allergic reactions and other idiosyncrasies have been rarely reported.

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  • OVERDOSAGE:

    Medical attention should be sought if more than a thin ribbon or pea-sized amount is accidentally swallowed. A thin ribbon or pea-sized amount of ControlRx dentifrice weighs approximately 0.3g and contains approximately 1.5mg of fluoride ion. A 2 oz tube contains 282mg of fluoride ion.

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  • DOSAGE AND ADMINISTRATION:

    Follow these instructions unless otherwise instructed by a dental professional. Use once daily.

    Apply a thin ribbon or pea-sized amount of ControlRx dentifrice to a soft-bristled toothbrush, and brush teeth for two minutes. After brushing, adults should expectorate. Children 6 to 16 years of age should expectorate and thoroughly rinse mouth with water.

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  • HOW SUPPLIED:

    2 oz (57g) net wt. of paste in laminate tubes.

    STORAGE: Do not freeze or expose to extreme heat.

    Rx Only

    Refreshing Vanilla Mint Flavor: 2 oz tube - NDC 48878-3100-6.

    MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.

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  • Principal Display Panel – Box Label

    3M ESPE

    NDC 48878-3100-6

    ControlRx

    Vanilla Mint

    1.1% Sodium Fluoride

    5000 ppm F- Prescription Toothpaste

    Rx Only

    OMNI

    Contents: 1 Tube

    NET WT 2oz (57g)

    Principal Display Panel – Box Label
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  • Principal Display Panel – Tube Label

    3M ESPE

    NDC 48878-3100-6

    ControlRx

    Vanilla Mint

    1.1% Sodium Fluoride

    5000 ppm F- Prescription Toothpaste

    Rx Only

    OMNI

    NET WT

    2oz (57g)

    Principal Display Panel – Tube Label
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  • INGREDIENTS AND APPEARANCE
    CONTROLRX 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:48878-3100
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sodium fluoride (fluoride ion) sodium fluoride 11 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Sorbitol  
    Silicon Dioxide  
    Glycerin  
    Dimethicone  
    Poloxamer 407  
    Polyethylene Glycol  
    Carboxymethylcellulose Sodium  
    Sodium Lauryl Sulfate  
    Titanium Dioxide  
    Saccharin Sodium  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (MINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48878-3100-6 1 in 1 BOX
    1 57 g in 1 TUBE
    2 NDC:48878-3100-2 2 in 1 BOX
    2 57 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/2005
    Labeler - 3M ESPE Dental Products (799975909)
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