Label: MASTIKIS MASTIC GUMCARE- silicon dioxide, aminocaproic acid paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 79814-009-01, 79814-009-02 - 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 10, 2021
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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
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- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MASTIKIS MASTIC GUMCARE
silicon dioxide, aminocaproic acid paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79814-009 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79814-009-02 1 in 1 CARTON 08/10/2021 1 NDC:79814-009-01 120 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 08/10/2021 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(79814-009)