ControlRx Multi

3M ESPE Dental Products

ControlRx™ Multi1.1% Sodium Fluoride Perscription Toothpaste

FULL PRESCRIBING INFORMATION: CONTENTS*

• CONTROLRX MULTI DESCRIPTION:
• CLINICAL PHARMACOLOGY:
• CONTROLRX MULTI INDICATIONS AND USAGE:
• CONTROLRX MULTI CONTRAINDICATIONS:
• WARNINGS:
• CONTROLRX MULTI ADVERSE REACTIONS:
• OVERDOSAGE:
• CONTROLRX MULTI DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:
• Principal Display Panel – Box Label
• Principal Display Panel – Tube Label

FULL PRESCRIBING INFORMATION

DESCRIPTION:

ControlRx Multi 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: Purified Water, Xylitol, Hydrated Silica, Glycerin, Cellulose Gum, Flavor, Simethicone, Sodium LaurylSulfate, Sodium Saccharin.

CLINICAL PHARMACOLOGY:

The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. ControlRx Multi 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 Multi dentifrice is indicated for use as part of a professional program for the prevention and control of dental caries. ControlRx Multi dentifrice is applied to the teeth using a toothbrush. ControlRx Multi 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 thinribbon or pea-sized amount of ControlRx Multi 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 Multi 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 Vanilla Mint Flavor: 2 oz tube - NDC 48878-3110-6

Principal Display Panel – Box Label

3M ESPE

NDC 48878-3110-6

ControlRx™ Multi

Vanilla Mint

1.1% Sodium Fluoride

Plus Xylitol

5000 ppm F ^- Prescription Toothpaste

Rx Only

OMNI _™

Contents: 1 Tube

Net WT 2oz (57g)