FDA.reportPublic FDA data

Mastikis Mastic 24K Whitening

Manufacturer
Mastic Korea.Co.Ltd | Sungwon Pharmaceutical Co., Ltd.
Effective date
2021-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:30

Label at a glance#

ProductMastikis Mastic 24K Whitening
Active ingredientHYDROGEN PEROXIDE, .ALPHA.-TOCOPHEROL ACETATE, SILICON DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide 7%

Hydrogen Peroxide Solution 2.14%

Tocopherol Acetate 0.2%

INACTIVE INGREDIENT SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children.

OTC - PURPOSE SECTION

Anti-gingivitis

Anti-plaque

WARNINGS SECTION

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 SECTION

- Brighter and healthier teeth and better oral hygiene

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

- Prevents periodontal and gum disease

DOSAGE & ADMINISTRATION SECTION

Brush teeth with a pea-sized amount

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79814-008-022023-01-30C16284748780-1f386c649-c9da-0266-e053-dadaa90a7c1a79814-008_Mastikis Mastic 24K Whitening Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79814-008-01Mastikis Mastic 24K Whitening110 g in 1 TUBEPASTE, DENTIFRICE1101
79814-008-02Mastikis Mastic 24K Whitening1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79814-008MASTIKIS MASTIC 24K WHITENING (HYDROGEN PEROXIDE SOLUTION, TOCOPHEROL ACETATE, COLLOIDAL SILICON DIOXIDE) PASTE, DENTIFRICE [MASTIC KOREA.CO.LTD]1Legacy NDC, 2 package rows20210129_0aa5f96d-9607-4bde-8401-ff3b44eebeb6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79814-00879814-008-01, 79814-008-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 60CAL22UVI4MIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
STEVIOSIDE0YON5MXJ9PIACT
CITRUS PARADISI SEED12F08874Y7IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SPEARMINT OILC3M81465G5IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
LEVOMENTHOLBZ1R15MTK7IACT
EUCALYPTUS OIL2R04ONI662IACT
LICORICE61ZBX54883IACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ba0077b2-fa19-06b2-e053-2a95a90a0dfd0aa5f96d-9607-4bde-8401-ff3b44eebeb62021-01-28WarningsExact identifier
spl id: ba0077b2-fa19-06b2-e053-2a95a90a0dfd
spl set id: 0aa5f96d-9607-4bde-8401-ff3b44eebeb6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.