Label: CONTROLRX- sodium fluoride paste, dentifrice
- NDC Code(s): 48878-3101-6
- Packager: 3M ESPE Dental Products
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated May 11, 2010
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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.
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.Close
- 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.Close
Do not use in children less than 6 years of age unless recommended by a dental professional.Close
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.Close
- ADVERSE REACTIONS:
Allergic reactions and other idiosyncrasies have been rarely reported.Close
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.Close
- 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.Close
- HOW SUPPLIED:
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.
- Principal Display Panel – Box Label
1.1% Sodium Fluoride
5000 ppm F- Prescription ToothpasteOMNI™
Contents: 1 Tube
NET WT 2oz (57g)Close
- Principal Display Panel – Tube Label
1.1% Sodium Fluoride
5000 ppm F- Prescription Toothpaste
- INGREDIENTS AND APPEARANCE
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48878-3101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) sodium fluoride 11 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Glycerin (UNII: PDC6A3C0OX) Dimethicone (UNII: 92RU3N3Y1O) Poloxamer 407 (UNII: TUF2IVW3M2) Polyethylene Glycol (UNII: 3WJQ0SDW1A) Carboxymethylcellulose Sodium (UNII: K679OBS311) Sodium Lauryl Sulfate (UNII: 368GB5141J) Titanium Dioxide (UNII: 15FIX9V2JP) Saccharin Sodium (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor BERRY (BERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48878-3101-6 1 in 1 BOX 1 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)