Mastikis Gold II

Manufacturer
Mastic Korea.Co.Ltd | Sungwon Pharmaceutical Co., Ltd.
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:37

Label at a glance#

ProductMastikis Gold II
Active ingredientSILICON DIOXIDE, SODIUM PYROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide 14.0%
Tetrasodium Pyrophosphate 0.5%

INACTIVE INGREDIENT SECTION

Tocopherol Acetate, D-Sorbitol Solution, Glycerin, Polyethylene Glycol1500, Carboxymethylcellulose Sodium, Trisodium Citrate, Xylitol, Steviol Glycoside, Bioactive Herb Complex-C(BHC-C), Hydroxyapatite, L-Menthol, Mastic oil, Grapefruit Seed Extract, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Deionized Water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children.

OTC - PURPOSE SECTION

Anti-plaque

WARNINGS SECTION

Ask a dentis before use if you have

- bleeding or redness lasting more than 2 weeks pain, welling, pus, loose teeth, or more spacing between teeth.

- These may be signs of periodontis, a serious from of gum disease

INDICATIONS & USAGE SECTION

Brighter and healthier teeth and better oral hygine

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
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
79814-002-022023-01-30C16284748780-1f386c64a-2ce2-0266-e053-dadaa90a7c1a79814-002_Mastikis Gold II toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79814-002-01Mastikis Gold II120 g in 1 TUBEPASTE, DENTIFRICE1201
79814-002-02Mastikis Gold II1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79814-002MASTIKIS GOLD II (SILICON DIOXIDE, TETRASODIUM PYROPHOSPHATE) PASTE, DENTIFRICE [MASTIC KOREA.CO.LTD]1Legacy NDC, 2 package rows20200814_0aa107f6-21af-4553-a8a2-e0e374fff257.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79814-00279814-002-01, 79814-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
acc6c1ac-5af0-e2cd-e053-2995a90aa11d0aa107f6-21af-4553-a8a2-e0e374fff2572020-08-13WarningsExact identifier
spl id: acc6c1ac-5af0-e2cd-e053-2995a90aa11d
spl set id: 0aa107f6-21af-4553-a8a2-e0e374fff257

Reported adverse events (FAERS/openFDA)#

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