BUBBLE CHEEE GOLD PLUS TOOTH- sodium fluoride, allantoin paste, dentifrice

Bubble Cheee Gold Plus Tooth by

Drug Labeling and Warnings

Bubble Cheee Gold Plus Tooth by is a Otc medication manufactured, distributed, or labeled by Nature Plus, KMPHARMACEUTICAL Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Sodium Fluoride 0.1%
Allantoin 0.05%

INACTIVE INGREDIENTS

Water, PEG-40 Hydrogenated castor oil, Sodium lauroyl sarcosinate, Xylitol, Mentha piperita(peppermint)oil, Citrus limon(lemon)Fruit oil, Methyl p-Hydroxy benzoate, Petersonii oil, Sodium saccharin

PURPOSE

Antiplaque
Prevents gingivitis and periodontitis

WARNINGS

The toothpaste contains 452ppm of fluorine. 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.

Uses

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

Directions

Pump into mouth or onto a toothbrush to gargle or brush daily.

Other Information

Keep in airtight container in room temperature(1~30°C).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUBBLE CHEEE GOLD PLUS TOOTH 
sodium fluoride, allantoin paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79428-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 50 mL
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.025 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79428-020-02	1 in 1 CARTON	07/01/2020
1	NDC: 79428-020-01	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		07/01/2020

Labeler - Nature Plus (688361245)

Registrant - Nature Plus (688361245)

Establishment
Name	Address	ID/FEI	Business Operations
KMPHARMACEUTICAL Co.,Ltd.		688679158	manufacture(79428-020)