MASTIKIDS II- silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate 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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79814-005_Mastikids II toothpaste

Silicon Dioxide 14%

Tocopherel Acetate 0.1%

Tetrasodium Pyrophosphate 0.5%

D-Sorbitol Solution, Glycerin, Carboxymethylcellulose Sodium, Trisodium Citrate, Xylitol, Steviol Glycoside, Hydroxyapatite, L-Menthol, Strawberry Flavor, Mastic Oil, Eucalyptus Oil, Grapefruit Seed Extract, Propolis Extract, Green Tea Extract, Aloe Extract, Sodium Cocoyl Glutamate, Deionized Water

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

MASTIKIDS II 
silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-005
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE14 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.1 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
XYLITOL (UNII: VCQ006KQ1E)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE (UNII: V5VD430YW9)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79814-005-021 in 1 CARTON09/14/2020
1NDC:79814-005-0170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/14/2020
Labeler - Mastic Korea.Co.Ltd (687791189)
Registrant - Mastic Korea.Co.Ltd (687791189)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-005)

Revised: 9/2020
Document Id: af4b2b10-098b-5fae-e053-2a95a90a2d0d
Set id: 18e00bbc-d7e8-43ba-a198-43a6fd06036d
Version: 1
Effective Time: 20200914
 
Mastic Korea.Co.Ltd