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| Product NDC Code | 83199-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Evernamel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416784 | ||||
| Application Number | part356 | ||||
| Labeler Name | Alpine Dental, Inc. | ||||
| 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 Ingredients Stannous Fluoride, 0.454%
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 • Remove seal • Apply a pea-sized amount of paste to the wet toothbrush Adults and Children 12 years or older: • Brush teeth thoroughly for one minute after ach meal at least twice a day (or as directed by a dentist or physician) • Do not swallow Children under 12 years of age: ask a dentist
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Sodium Gluconate, Flavor, Zinc Citrate, Quillaja Saponica Bark Extract, Cocamidopropyl Betaine, Titanium Dioxide, Smilax Aristolochiaefolia Root Extract, Sodium Hydroxide, Sodium Hydroxide, Sodium Tripolyphosphate, Tocopheryl Acetate, Xanthan Gum, Natural Menthol, Yucca Schidigera Rooth Extract, Dioscorea Villosa Root Extract
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 • Builds up the enamel of teeth • Aids in the prevention of cavities • Helps prevent gingivitis • Helps sensitive teeth
Purpose
Information about the drug product’s indications for use.Purpose Anti-cavity & Anti-gingivitis
Spl product data elements
Usually a list of ingredients in a drug product.Evernamel Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA XYLITOL GLYCERIN SODIUM GLUCONATE ZINC CITRATE QUILLAJA SAPONARIA BARK COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE SMILAX ARISTOLOCHIIFOLIA ROOT SODIUM HYDROXIDE SODIUM TRIPOLYPHOSPHATE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM MENTHOL YUCCA SCHIDIGERA ROOT DIOSCOREA VILLOSA WHOLE
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.Evernamel Brush Your Way To a Brighter Smile Fresh Spearmint Evernamel Toothpaste with Remineralizing Benefits Anticavity / Antigingivitis / Sensitivity Relief 122 g / 4.3 oz. 20230123_83199_102_43
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 • Everest enamel was specially formulated to prevent surface stains on the teeth, which otherwise can occur while using Stannous Fluoride. • Adequate tooth brushing may also prevent Stannous Fluoride stains which are not harmful or permanent and can be removed by a Dentist
Questions or comments? Call toll free 1-800-553-3682
Manufactured for: Alpine Dental, Inc. Brooklyn, NY 11218 Made in the USA Item Code 1520-10
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.Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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.Warnings
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