MASTIKIS MASTIC GUMCARE- silicon dioxide, aminocaproic acid paste, dentifrice

Mastikis Mastic GumCare by

Drug Labeling and Warnings

Mastikis Mastic GumCare by is a Otc medication manufactured, distributed, or labeled by Mastic Korea.Co.Ltd, Sungwon Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silicon Dioxide 16%

Aminocaproic Acid 0.1%

INACTIVE INGREDIENT

D-Sorbitol Solution, Glycerin, Carboxymethylcellulose Sodium, Corn Starch, Xylitol, Steviol Glycoside, Sodium Ascorbate, Hydroxyapatite, Sodium Bicarbonate, L-Menthol, Mastic Oil, Mentha Oil, Olive Oil, Eucalyptus Oil, Grapefruit Seed Extract, Glycyrrhiza Extract, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Deionized Water

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children.

PURPOSE

Anti-cavity

Anti-gingivitis

WARNINGS

Ask a dentist before use if you have

- bleeding or redness lasting more than 2 weeks pain, swelling, pus, losse teeth, or more spacing between teeth

- These may be signs of periodontitis, a serious form of gum disease

INDICATIONS & USAGE

- Healthier teeth and gums, and better oral hygiene.

- Anti-caries, anti-plaque, anti-gingivitis

- Prevents periodontal and gum disease

DOSAGE & ADMINISTRATION

Brush teeth with a pea-sized amount

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MASTIKIS MASTIC GUMCARE 
silicon dioxide, aminocaproic acid paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79814-009
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	16 g  in 100 g
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
STARCH, CORN (UNII: O8232NY3SJ)
XYLITOL (UNII: VCQ006KQ1E)
STEVIOSIDE (UNII: 0YON5MXJ9P)
SODIUM ASCORBATE (UNII: S033EH8359)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
LEVOMENTHOL (UNII: BZ1R15MTK7)
OLIVE OIL (UNII: 6UYK2W1W1E)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
LICORICE (UNII: 61ZBX54883)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79814-009-02	1 in 1 CARTON	08/10/2021
1	NDC: 79814-009-01	120 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		08/10/2021

Labeler - Mastic Korea.Co.Ltd (687791189)

Registrant - Mastic Korea.Co.Ltd (687791189)

Establishment
Name	Address	ID/FEI	Business Operations
Sungwon Pharmaceutical Co., Ltd.		689787898	manufacture(79814-009)