ENAMELON- stannous fluoride paste, dentifrice

Enamelon by

Drug Labeling and Warnings

Enamelon by is a Otc medication manufactured, distributed, or labeled by Premier Dental Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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

Questions or comments?

Call toll-free 1-888-670-6100

Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST

Distributed By

Premier® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com Part # 9007280www.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!

ACPTM Enamel Therapy

Premier®

Enamelon®

Mint Breeze

Fluoride Toothpaste NET WT 4.3 OZ (122 g)

For Anticavity, Antigingivitis & Sensitive Teeth

ULTRAMULSION®

NDC: 48783-520-43

PRINCIPAL DISPLAY PANEL

STRENGTHEN YOUR SMILE!

ACPTM 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

INGREDIENTS AND APPEARANCE

ENAMELON 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48783-520
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.00454 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) (UNII: 5216H1HX5F)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CALCIUM SULFATE (UNII: WAT0DDB505)
POLOXAMER 407 (UNII: TUF2IVW3M2)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAUROYL SARCOSINE (UNII: LIJ19P3L6F)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT (Mint Breeze)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48783-520-43	1 in 1 CARTON	01/01/2014
1		122 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 48783-520-08	1 in 1 CARTON	01/01/2014
2		21.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2014

Labeler - Premier Dental Products Company (014789663)