Active Ingredient
Active ingredients: CALCIUM CARBONATE 30.0%, ANHYDROUS DIBASIC CALCIUM PHOSPHATE 0.1%, ALCLOXA 0.1%, AMINOCAPROIC ACID 0.1%
28tak Gum Care Tooth
FDA Label NDC 72440-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elmeditec Co.,ltd for the product 28tak Gum Care Tooth (NDC 72440-030). 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, inactive ingredient, purpose, warnings, keep out of reach of children, uses, directions, 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
Inactive Ingredient
Inactive ingredients:
D-Sorbitol Solution, Aqua, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xantangum, L-Menthol, Peppermint Oil, Mint Flavor, Propolis Powder, Xylitol, Green Tea Extract, Eucalyptus Extract, Chamomile Extract, Sage Extract, Aloe Extract, Taraxacum officinale Extract, Olive leaf extract, Mastic Oil
Purpose
Purpose: Anticavity
Warnings
Warnings:
(1) Do not swallow and rinse mouth thoroughly after use (2) If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. (3) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. (4) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. (5) Keep out of the reach of children under 6 years of age.
Keep Out Of Reach Of Children
Keep out of the reach of children under 6 years of age.
Uses
Uses:
Keep your teeth white and strong. Keep your mouth clean. Refresh the inside of the mouth. To prevent tooth decay and remove bad breath. Increase esthetic effect. Removal of plaque (anti-plaque)
Directions
Directions:
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2 years: Ask a dentist or physician
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