Enamelon

Premier Dental Products Company

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Enamelon Uses
• Warnings
• Directions
• Enamelon Other information
• Inactive ingredients
• Questions or comments?
• Distributed By
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Enamelon Uses

• Aids in the prevention of caries
• 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.

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.

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.

Enamelon 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, pvm/ma copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, TiO₂, flavor, acesulfame k, monosodium phosphate, sucralose

Questions or comments?

Call toll-free 1-888-670-6100 Monday-Friday 8am – 5pm EST

Distributed By

Premier^® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com www.enamelon.com

United States Patent Numbers : US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A.

Ultramulsion^® is a registered trademark of WhiteHill Oral Technologies, Inc.

PRINCIPAL DISPLAY PANEL

STRENGTHEN YOUR SMILE!

ACP^TM Enamel Therapy

Premier^®

Enamelon Fluoride Toothpaste

For Anticavity, Antigingivitis & Sensitive Teeth

Mint Breeze

NET WT 4.3 OZ (122 g)

ULTRAMULSION^®

NDC 48783-520-43

STRENGTHEN YOUR SMILE!

ACP^TM Enamel Therapy

Premier^®

Enamelon Fluoride Toothpaste

For Anticavity, Antigingivitis & Sensitive Teeth

Mint Breeze

NET WT 0.75 OZ (21.2 g)

ULTRAMULSION^®

NDC 48783-520-08