MASTIKIS MASTIC 24K WHITENING- hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide 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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79814-008_Mastikis Mastic 24K Whitening Toothpaste

Colloidal Silicon Dioxide 7%

Hydrogen Peroxide Solution 2.14%

Tocopherol Acetate 0.2%

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.

Anti-gingivitis

Anti-plaque

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

- Brighter and healthier teeth 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 24K WHITENING 
hydrogen peroxide solution, tocopherol acetate, colloidal silicon dioxide paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-008
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79814-008-021 in 1 CARTON01/28/2021
1NDC:79814-008-01110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/28/2021
Labeler - Mastic Korea.Co.Ltd (687791189)
Registrant - Mastic Korea.Co.Ltd (687791189)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-008)

Revised: 1/2021
Document Id: ba0077b2-fa19-06b2-e053-2a95a90a0dfd
Set id: 0aa5f96d-9607-4bde-8401-ff3b44eebeb6
Version: 1
Effective Time: 20210128
 
Mastic Korea.Co.Ltd