MASTIKIS GOLD- silicon dioxide, aminocaproic acid paste, dentifrice

mastikis gold by

Drug Labeling and Warnings

mastikis gold 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

Aminocaproic Acid 0.1%
Silica 16%

INACTIVE INGREDIENT

D-Sorbitol Solution, Deionized Water, Glycerin, Mastic oil, Sodium Lauryl Sulfate, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Grapefruit Seed Extract, Xylitol, Steviol Glycoside, Hydroxyapatite, L-Menthol, Ascorbic Acid, Tocopherol Acetate

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children.

PURPOSE

Anti-cavity

Anti-plaque

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Aids in the cleanness of teeth and protection of gum health

DOSAGE & ADMINISTRATION

Supervise children as necessary until capable of using without supervision.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MASTIKIS GOLD 
silicon dioxide, aminocaproic acid paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79814-001
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)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
XYLITOL (UNII: VCQ006KQ1E)
STEVIOSIDE (UNII: 0YON5MXJ9P)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
LEVOMENTHOL (UNII: BZ1R15MTK7)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79814-001-02	1 in 1 CARTON	07/31/2020
1	NDC: 79814-001-01	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		07/31/2020

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(79814-001)