MASTIKIS MASTIC 24K WHITENING- hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide paste, dentifrice

Mastikis Mastic 24K Whitening by

Drug Labeling and Warnings

Mastikis Mastic 24K Whitening by is a Otc medication manufactured, distributed, or labeled by Mastic Korea.Co.Ltd, Sungwon Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Colloidal Silicon Dioxide 7%

Hydrogen Peroxide Solution 2.14%

Tocopherol Acetate 0.2%

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

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children.

PURPOSE

Anti-gingivitis

Anti-plaque

WARNINGS

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

INDICATIONS & USAGE

- Brighter and healthier teeth and better oral hygiene

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

- Prevents periodontal and gum disease

DOSAGE & ADMINISTRATION

Brush teeth with a pea-sized amount

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MASTIKIS MASTIC 24K WHITENING 
hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide paste, dentifrice

Product 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)