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| Product NDC Code | 48783-500 | ||||
|---|---|---|---|---|---|
| Drug Name | Enamelon preventive treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 237847 | ||||
| Application Number | M021 | ||||
| Labeler Name | Premier Dental Products Company | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous fluoride 0.40% (0.15% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Anticavity/Sensitivity Relief/Antigingivitis
Spl product data elements
Usually a list of ingredients in a drug product.Enamelon Preventive Treatment stannous fluoride ACESULFAME POTASSIUM CALCIUM SULFATE CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) COCAMIDOPROPYL BETAINE DIMETHICONE GLYCERIN LAUROYL SARCOSINE SODIUM PHOSPHATE, MONOBASIC POLOXAMER 407 POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SUCRALOSE STANNOUS FLUORIDE FLUORIDE ION Clean Mint
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL STRENGTHEN YOUR SMILE! ACP TM Enamel Therapy Premier ® Enamelon ® Preventive Treatment Gel NET WT 4.0 OZ (113 g) SENSITIVITY & DRY MOUTH Clean Mint HYDRAMULSION ® Enamelon Gel Box
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Warnings Keep out of the reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll-free 1-888-670-6100 Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API