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  5. Label Information: Enamelon

FDA Label for Enamelon

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS?
    9. DISTRIBUTED BY
    10. PRINCIPAL DISPLAY PANEL

Enamelon Product Label

The following document was submitted to the FDA by the labeler of this product Premier Dental Products Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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

premier Enamelon Fluoride Toothpaste Mint Breeze 4.3 OZ (122 g) - toothpaste

premier Enamelon Fluoride Toothpaste Mint Breeze 4.3 OZ (122 g) - toothpaste


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