MASTIKIS GOLD II- silicon dioxide, tetrasodium pyrophosphate paste, dentifrice 
Mastic Korea.Co.Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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79814-002_Mastikis Gold II toothpaste

Silicon Dioxide 14.0%
Tetrasodium Pyrophosphate 0.5%

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.

Anti-plaque

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

Brighter and healthier teeth and better oral hygine

Anti-caries, anti-plaque, anti-gingivitis

Prevents periodontal and gum disease

Brush teeth with a pea-sized amount

image description

MASTIKIS GOLD II 
silicon dioxide, tetrasodium pyrophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE14 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79814-002-021 in 1 CARTON08/13/2020
1NDC:79814-002-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/13/2020
Labeler - Mastic Korea.Co.Ltd (687791189)
Registrant - Mastic Korea.Co.Ltd (687791189)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-002)

Revised: 8/2020
Document Id: acc6c1ac-5af0-e2cd-e053-2995a90aa11d
Set id: 0aa107f6-21af-4553-a8a2-e0e374fff257
Version: 1
Effective Time: 20200813
 
Mastic Korea.Co.Ltd