YOOWOO BUBBLE TOOTH- allantoin paste, dentifrice

YooWoo Bubble Tooth by

Drug Labeling and Warnings

YooWoo Bubble 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

Allantoin 0.05%

INACTIVE INGREDIENT

WATER, SORBITOL, GLYCERIN, COCAMIDOPROPYL BETAINE, POLYSORBATE 60, MENTHA PIPERITA(PEPPERMINT)OIL, CITRUS LIMON(LEMON)FRUIT OIL, TEA TREE OIL, STEVIA REBAUDIANA EXTRACT, SODIUM CITRATE, XYLITOL, ERYTHRITOL, SODIUM BENZOATE

PURPOSE

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)

■ Effectively prevents cavities, gum diseases, halitosis and keeps the mouth clean and fresh after just 30 seconds of use.

DOSAGE & ADMINISTRATION

Directions

■ Pump directly into the mouth or onto a toothbrush for daily gargling or brushing.

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 BUBBLE TOOTH 
allantoin paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84875-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84875-020-02	1 in 1 CARTON	10/01/2024
1	NDC: 84875-020-01	50 mL in 1 BOTTLE, PUMP; 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(84875-020)