C
Dosage Form: oral paste, dentifrice
ControlRx™
1.1% Sodium Fluoride Prescription Toothpaste
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 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.
ADVERSE REACTIONS:
Allergic reactions and other idiosyncrasies have been rarely reported.
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.
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.
HOW SUPPLIED:
2 oz (57g) net wt. of paste in laminate tubes.
STORAGE: Do not freeze or expose to extreme heat.
Rx Only
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
3M ESPE
NDC 48878-3101-6
ControlRx™
Berry
1.1% Sodium Fluoride
5000 ppm F- Prescription ToothpasteOMNI™
Rx Only
Contents: 1 Tube
NET WT 2oz (57g)
Principal Display Panel – Tube Label
3M ESPE
NDC 48878-3101-6
ControlRx™
Berry
1.1% Sodium Fluoride
5000 ppm F- Prescription Toothpaste
Rx Only
OMNI™
NET WT
2oz (57g)
CONTROLRX
sodium fluoride paste, dentifrice
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
NDC Product Code (Source)
48878-3101
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
BERRY (BERRY)
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
48878-3101-6
1 TUBE In 1 BOX
contains a TUBE
1
57 g In 1 TUBE
This package is contained within the BOX (48878-3101-6)
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)
Revised: 05/20103M ESPE Dental Products
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Prevention of Dental Caries
ControlRx Toothpaste
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