Active Ingredient
Stannous fluoride 0.40% (0.15% w/v fluoride ion)
Enamelon Preventive Treatment Gel
FDA Label NDC 48783-500
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 Preventive Treatment (NDC 48783-500). 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
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?
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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
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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)
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