MASTIKIS GOLD II- silicon dioxide, tetrasodium pyrophosphate paste, dentifrice

Mastikis Gold II by

Drug Labeling and Warnings

Mastikis Gold II 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 14.0%
Tetrasodium Pyrophosphate 0.5%

INACTIVE INGREDIENT

Tocopherol Acetate, D-Sorbitol Solution, Glycerin, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Trisodium Citrate, Xylitol, Steviol Glycoside, Bioactive Herb Complex-C(BHC-C), Hydroxyapatite, L-Menthol, Mastic oil, Grapefruit Seed Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Deionized Water

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children.

PURPOSE

Anti-plaque

WARNINGS

Ask a dentis before use if you have

- bleeding or redness lasting more than 2 weeks pain, welling, pus, loose teeth, or more spacing between teeth.

- These may be signs of periodontis, a serious from of gum disease

INDICATIONS & USAGE

Brighter and healthier teeth and better oral hygine

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 GOLD II 
silicon dioxide, tetrasodium pyrophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79814-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	14 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
XYLITOL (UNII: VCQ006KQ1E)
STEVIOSIDE (UNII: 0YON5MXJ9P)
LEVOMENTHOL (UNII: BZ1R15MTK7)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79814-002-02	1 in 1 CARTON	08/13/2020
1	NDC: 79814-002-01	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		08/13/2020

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(79814-002)