Otc - Active Ingredient
Silica 6.0%
Tocopheryl Acetate 0.1%
Yoowoo Tooth
FDA Label NDC 84875-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yoowoomedix for the product Yoowoo Tooth (NDC 84875-010). 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 - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
WATER, SORBITOL, GLYCERIN, HYDRATED SILICA, SODIUM COCOYL GLUTAMATE, SODIUM BICARBONATE, CELLULOSE GUM, SODIUM METAPHOSPHATE, XYLITOL, STEVIA REBAUDIANA EXTRACT, TITANIUM DIOXIDE, MENTHA PIPERITA(PEPPERMINT)OIL, CITRUS LIMON(LEMON)FRUIT OIL, TEA TREE OIL
Otc - Purpose
Antiplaque
Prevents gingivitis and periodontitis
Warnings
■ Do not swallow, Rinse mouth after use. Stop use and consult a dentist or a doctor if anomalies occur in the mouth or on the gums after use. For children under 6 years use a pea-sized amount per use and supervise brushing to minimize swallowing. If more than used for brushing is swallowed by children under 6 years, consult a doctor or a dentist immediately. Keep out of reach of children under 6 years of age.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Indications & Usage
Use(s)
■ Helps to protect against cavity and gingivitis inducing bacteria, as well as halitosis.
Dosage & Administration
Directions
■ Apply product onto a toothbrush and brush teeth. Use a smaller amount than other toothpaste for children or those more sensitive to taste. Keep the lid closed after each use. Brush teeth for 3 minutes or longer with YooWoo Toothpaste for better results.
Other Safety Information
Other Information
■ Keep in an airtight container at room temperature(1~30°C).
Otc - Questions
■ www.YooWooMedix.com
■ 82-2-1660-4588
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