ControlRx Toothpaste

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