Enamelon Preventive Treatment .004 g/g

stannous fluoride · GEL · Premier Dental Products Company

No Recall History

Plain English

Enamelon Preventive Treatment is a gel containing stannous fluoride at .004 g/g, taken dental. Manufactured by Premier Dental Products Company.

Key Facts

Brand Name: Enamelon Preventive Treatment
Generic Name: stannous fluoride
NDC Code (Product): 48783-500
Manufacturer: Premier Dental Products Company
Strength: .004 g/g
Dosage Form: GEL
Route: DENTAL
Marketing Status
Application #: M021
Marketing Start: 01/01/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

oral discomfort5 reports

dyspnoea4 reports

oral disorder4 reports

oral pain4 reports

anaemia3 reports

fatigue3 reports

gingival discomfort3 reports

nausea3 reports

off label use3 reports

platelet count decreased3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Aids in the prevention of cavities Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact Helps prevent gingivitis Helps interfere with the harmful effects of plaque associated with gingivitis

Dosage & Administration

Directions Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.

Frequently Asked Questions

What is Enamelon Preventive Treatment used for?

Enamelon Preventive Treatment contains stannous fluoride. It is a gel taken dental. Consult your doctor for specific uses.

Is Enamelon Preventive Treatment a controlled substance?

Enamelon Preventive Treatment is not classified as a controlled substance by the DEA.

What is the generic name for Enamelon Preventive Treatment?

The generic name for Enamelon Preventive Treatment is stannous fluoride. There are 12 other brand versions of stannous fluoride.

What is the NDC code for Enamelon Preventive Treatment .004 g/g?

The NDC (National Drug Code) for Enamelon Preventive Treatment .004 g/g is 48783-500, listed by Premier Dental Products Company.

Product NDC

48783-500

Package NDC

48783-500-40

Other Stannous Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)