ControlRx Multi Toothpaste

Name: ControlRx Multi Toothpaste

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.

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.

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.

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

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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