MASTIKIDS II- silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice

Mastikids II by

Drug Labeling and Warnings

Mastikids II 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

Silicon Dioxide 14%

Tocopherel Acetate 0.1%

Tetrasodium Pyrophosphate 0.5%

INACTIVE INGREDIENT

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

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

MASTIKIDS II 
silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79814-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	14 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.1 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79814-005-02	1 in 1 CARTON	09/14/2020
1	NDC: 79814-005-01	70 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		09/14/2020

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(79814-005)