Mastikids II

Manufacturer
Mastic Korea.Co.Ltd | Sungwon Pharmaceutical Co., Ltd.
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:13

Label at a glance#

ProductMastikids II
Active ingredientSILICON DIOXIDE, .ALPHA.-TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide 14%

Tocopherel Acetate 0.1%

Tetrasodium Pyrophosphate 0.5%

INACTIVE INGREDIENT SECTION

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

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
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
79814-005-022023-01-30C16284748780-1f386c64a-3939-0266-e053-dadaa90a7c1a79814-005_Mastikids II toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79814-005-01Mastikids II70 g in 1 TUBEPASTE, DENTIFRICE701
79814-005-02Mastikids II1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79814-005MASTIKIDS II (SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE) PASTE, DENTIFRICE [MASTIC KOREA.CO.LTD]1Legacy NDC, 2 package rows20200915_18e00bbc-d7e8-43ba-a198-43a6fd06036d.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79814-00579814-005-01, 79814-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
af4b2b10-098b-5fae-e053-2a95a90a2d0d18e00bbc-d7e8-43ba-a198-43a6fd06036d2020-09-14WarningsExact identifier
spl id: af4b2b10-098b-5fae-e053-2a95a90a2d0d
spl set id: 18e00bbc-d7e8-43ba-a198-43a6fd06036d

Reported adverse events (FAERS/openFDA)#

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