Enamelon Paste, Dentifrice
FDA Label NDC 48783-520

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Dental Products Company for the product Enamelon (NDC 48783-520). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Distributed By

→ Principal Display Panel

Active Ingredient

Stannous fluoride 0.45% (0.16% w/v fluoride ion)

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

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

Warnings

Keep out of the reach of children under 6 years of age.

Directions

Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Other Information

Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Do not use if foil seal on tube is broken or missing
Keep tightly closed when not in use
Store at controlled room temperature

Inactive Ingredients

Glycerin, polyethylene glycol, silica, calcium/sodium maleate methyl vinyl ether copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, titanium dioxide, flavor, acesulfame k, monosodium phosphate, sucralose