MASTIKIS MASTIC GUMCARE- 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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79814-009_Mastikis Mastic GumCare Toothpaste

Silicon Dioxide 16%

Aminocaproic Acid 0.1%

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.

Anti-cavity

Anti-gingivitis

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

- Healthier teeth and gums, and better oral hygiene.

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

- Prevents periodontal and gum disease

Brush teeth with a pea-sized amount

image description

MASTIKIS MASTIC GUMCARE 
silicon dioxide, aminocaproic acid paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-009
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79814-009-021 in 1 CARTON08/10/2021
1NDC:79814-009-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/10/2021
Labeler - Mastic Korea.Co.Ltd (687791189)
Registrant - Mastic Korea.Co.Ltd (687791189)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-009)

Revised: 8/2021
Document Id: c93cf2e3-489a-38d5-e053-2a95a90a2e9b
Set id: daf789be-0061-4188-9ab4-540044a0df05
Version: 1
Effective Time: 20210810
 
Mastic Korea.Co.Ltd