Label: MASTIKIS MASTIC 24K- silicon dioxide, aminocaproic acid paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 79814-003-01, 79814-003-02 - Packager: Mastic Korea.Co.Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated August 14, 2020
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
D-Sorbitol Solution, Glycerin, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Hydroxyapatite, Sodium Bicarbonate, Bamboo salt, Xylitol, Steviol Glycoside, L-Menthol, Grapefruit Seed Extract, Mastic Oil, Olive Oil, Phytonside flavour, Glycyrrhiza Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Deionized Water
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- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MASTIKIS MASTIC 24K
silicon dioxide, aminocaproic acid paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79814-003 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) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) SODIUM BICARBONATE (UNII: 8MDF5V39QO) XYLITOL (UNII: VCQ006KQ1E) STEVIOSIDE (UNII: 0YON5MXJ9P) LEVOMENTHOL (UNII: BZ1R15MTK7) CITRUS PARADISI SEED (UNII: 12F08874Y7) OLIVE OIL (UNII: 6UYK2W1W1E) LICORICE (UNII: 61ZBX54883) 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:79814-003-02 1 in 1 CARTON 08/14/2020 1 NDC:79814-003-01 110 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 08/14/2020 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(79814-003)