ControlRx™1.1% Sodium Fluoride Prescription Toothpaste

CONTROLRX - sodium fluoride paste, dentifrice 
3M ESPE Dental Products

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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 – Box Label

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)

Principal Display Panel – Tube Label

CONTROLRX 
sodium fluoride   paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)48878-3101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (fluoride ion) sodium fluoride11 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Silicon Dioxide 
Glycerin 
Dimethicone 
Poloxamer 407 
Polyethylene Glycol 
Carboxymethylcellulose Sodium 
Sodium Lauryl Sulfate 
Titanium Dioxide 
Saccharin Sodium 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (BERRY) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
148878-3101-61 TUBE In 1 BOXcontains a TUBE
157 g In 1 TUBEThis package is contained within the BOX (48878-3101-6)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/2005

Labeler - 3M ESPE Dental Products (799975909)
Establishment
NameAddressID/FEIOperations
Sheffield Pharmaceuticals151177797MANUFACTURE
Revised: 05/20103M ESPE Dental Products