CONTROLRX - sodium fluoride paste, dentifrice
3M ESPE Dental Products
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.
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.
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.
Do not use in children less than 6 years of age unless recommended by a dental professional.
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.
Allergic reactions and other idiosyncrasies have been rarely reported.
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.
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.
2 oz (57g) net wt. of paste in laminate tubes.
STORAGE: Do not freeze or expose to extreme heat.
Refreshing Berry Flavor: 2 oz tube - NDC 48878-3101-6.
MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.
1.1% Sodium Fluoride
5000 ppm F- Prescription ToothpasteOMNI™
Contents: 1 Tube
NET WT 2oz (57g)
1.1% Sodium Fluoride
5000 ppm F- Prescription Toothpaste
sodium fluoride paste, dentifrice
|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)|