ControlRx Toothpaste
Generic name:sodium fluoride
Dosage form: oral paste, dentifrice
Drug class:Mouth and throat products
Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.
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.
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The ControlRx Toothpaste brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.
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.
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.
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.
CONTRAINDICATIONS:
Do not use in children less than 6 years of age unless recommended by a dental professional.
WARNINGS:
Do not swallow. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less tha...
