YOOWOO TOOTH- silica, tocopheryl acetate paste, dentifrice

YooWoo Tooth by

Drug Labeling and Warnings

YooWoo Tooth by is a Otc medication manufactured, distributed, or labeled by YOOWOOMEDIX, KMPHARMACEUTICAL Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silica 6.0%

Tocopheryl Acetate 0.1%

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

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.

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).

QUESTIONS

■ www.YooWooMedix.com

■ 82-2-1660-4588

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YOOWOO TOOTH 
silica, tocopheryl acetate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84875-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	0.1 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84875-010-02	1 in 1 CARTON	10/01/2024
1	NDC: 84875-010-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2024

Labeler - YOOWOOMEDIX (695355731)

Registrant - YOOWOOMEDIX (695355731)

Establishment
Name	Address	ID/FEI	Business Operations
KMPHARMACEUTICAL Co.,Ltd.		689850153	manufacture(84875-010)