MASTIKIS GOLD- silicon dioxide, aminocaproic acid 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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79814-001_mastikis gold toothpaste

Aminocaproic Acid 0.1%
Silica 16%

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.

Anti-cavity

Anti-plaque

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

Aids in the cleanness of teeth and protection of gum health

Supervise children as necessary until capable of using without supervision.

image description

MASTIKIS GOLD 
silicon dioxide, aminocaproic acid paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE16 g  in 100 g
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79814-001-021 in 1 CARTON07/31/2020
1NDC:79814-001-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/31/2020
Labeler - Mastic Korea.Co.Ltd (687791189)
Registrant - Mastic Korea.Co.Ltd (687791189)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-001)

Revised: 7/2020
Document Id: abc79e00-71e8-ce41-e053-2a95a90a3fe5
Set id: 619bd3a9-6fcd-4ad7-9253-082aa341cf95
Version: 1
Effective Time: 20200731
 
Mastic Korea.Co.Ltd