Label: MASTIKIS MASTIC 24K WHITENING- hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 79814-008-01, 79814-008-02 - Packager: Mastic Korea.Co.Ltd
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 28, 2021
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
D-Sorbitol Solution, Water, Glycerin, Mastic Oil, PCarboxymethylcellulose Sodium, Xantahan Gum, Polysorbate 60, Titanium Oxide, Citric Acid, Zylitol, Steviol Glycoside, Grapefruit Seed Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Mentha Oil, Spearmint oil, Tocopherol Acetate, Hydroxyapatite, L-Menthol, Eucalyptus Oil, Phytonside flavour, Glycyrrhiza Extract
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- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MASTIKIS MASTIC 24K WHITENING
hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79814-008 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 2.14 g in 100 g .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 0.2 g in 100 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 7 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 60 (UNII: CAL22UVI4M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XYLITOL (UNII: VCQ006KQ1E) STEVIOSIDE (UNII: 0YON5MXJ9P) CITRUS PARADISI SEED (UNII: 12F08874Y7) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SPEARMINT OIL (UNII: C3M81465G5) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) LEVOMENTHOL (UNII: BZ1R15MTK7) EUCALYPTUS OIL (UNII: 2R04ONI662) LICORICE (UNII: 61ZBX54883) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79814-008-02 1 in 1 CARTON 01/28/2021 1 NDC:79814-008-01 110 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 01/28/2021 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(79814-008)