Mastikis Mastic Gumcare
FDA Label NDC 79814-009

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mastic Korea.co.ltd for the product Mastikis Mastic Gumcare (NDC 79814-009). 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 otc - active ingredient, inactive ingredient, otc - keep out of reach of children, otc - purpose, warnings, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Silicon Dioxide 16%

Aminocaproic Acid 0.1%

Inactive Ingredient

D-Sorbitol Solution, Glycerin, Carboxymethylcellulose Sodium, Corn Starch, Xylitol, Steviol Glycoside, Sodium Ascorbate, Hydroxyapatite, Sodium Bicarbonate, L-Menthol, Mastic Oil, Mentha Oil, Olive Oil, Eucalyptus Oil, Grapefruit Seed Extract, Glycyrrhiza Extract, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Deionized Water

Otc - Keep Out Of Reach Of Children

Keep out of Reach of Children.

Otc - Purpose

Anti-cavity

Anti-gingivitis

Warnings

Ask a dentist before use if you have

- bleeding or redness lasting more than 2 weeks pain, swelling, pus, losse teeth, or more spacing between teeth

- These may be signs of periodontitis, a serious form of gum disease

Indications & Usage

- Healthier teeth and gums, and better oral hygiene.

- Anti-caries, anti-plaque, anti-gingivitis

- Prevents periodontal and gum disease

Dosage & Administration

Brush teeth with a pea-sized amount

Package Label.Principal Display Panel

Image Description (Gumcare)

Image Description (Gumcare)

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