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  5. Label Information: Enamelon Preventive Treatment

FDA Label for Enamelon Preventive Treatment

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. OTHER
    10. PRINCIPAL DISPLAY PANEL

Enamelon Preventive Treatment 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 0.40% (0.15% 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.


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.


Other Information



This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. 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 is broken or missing
  • Keep tightly closed when not in use
  • Store at controlled room temperature

Inactive Ingredients



Acesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, sucralose


Questions Or Comments?



Call toll-free 1-888-670-6100
Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST


Other



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.

Clinically Proven Active Ingredient for Anticavity, Antigingivitis and Sensitive Teeth

  • Relieves the discomfort of dry mouth tissues
  • Non-irritating to patients with dry mouth
  • Optimized with calcium and phosphate ions
  • No Sodium Lauryl Sulfate (SLS), No Gluten, No Dyes

    • ​Distributed by:

    Premier® Dental Products Company, Plymouth Meeting, PA 19462

    www.premusa.com Part # 9007285 www.enamelon.com

    NDC 48783-500-40 021665 Rev4 SP


Principal Display Panel



STRENGTHEN YOUR SMILE!

ACPTM Enamel Therapy

Premier®

Enamelon®

Preventive Treatment Gel

NET WT 4.0 OZ (113 g)

SENSITIVITY & DRY MOUTH

Clean Mint

ULTRAMULSION®

premier Enamelon Preventive Treatment Gel Clean Mint 4.0 OZ (113 g) - gel

premier Enamelon Preventive Treatment Gel Clean Mint 4.0 OZ (113 g) - gel


* Please review the disclaimer below.