Evernamel
FDA Label NDC 83199-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alpine Dental, Inc. for the product Evernamel (NDC 83199-102). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Stannous Fluoride, 0.454%

Purpose

Anti-cavity & Anti-gingivitis

Uses

• Builds up the enamel of teeth
• Aids in the prevention of cavities
• Helps prevent gingivitis
• Helps sensitive teeth

Warnings

Otc - Keep Out Of Reach Of Children

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.

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

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

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

Questions Or Comments?

Call toll free 1-800-553-3682

Other

Manufactured for:

Alpine Dental, Inc.

Brooklyn, NY 11218

Made in the USA

Item Code 1520-10

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 (20230123 83199 102 43)

20230123_83199_102_43 (20230123 83199 102 43)

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