FDA.reportPublic FDA data

Mastikis Qingxin Care Mastic

Manufacturer
Mastic Korea.Co.Ltd | Sungwon Pharmaceutical Co., Ltd.
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:50

Label at a glance#

ProductMastikis Qingxin Care Mastic
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, Polyethylene Glycol1500, Trisodium Citrate, Carboxymethylcellulose Sodium, Bamboo salt, Xylitol, Steviol Glycoside, Bioactive Herb Complex-C(BHC-C), Allura Red AC, L-Menthol, Grapefruit Seed Extract, Mastic oil, Rose Extract, Propolis Extract, Aloe Extract, Eucalyptus Oil, 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-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
79814-006-022023-01-30C16284748780-1f386c64a-16be-0266-e053-dadaa90a7c1a79814-006_Mastikis Qingxin Care Mastic Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79814-006-01Mastikis Qingxin Care Mastic120 g in 1 TUBEPASTE, DENTIFRICE1201
79814-006-02Mastikis Qingxin Care Mastic1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79814-006MASTIKIS QINGXIN CARE MASTIC (SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE) PASTE, DENTIFRICE [MASTIC KOREA.CO.LTD]1Legacy NDC, 2 package rows20200922_2c74e751-6c66-473a-aece-38d83fd47c48.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
79814-00679814-006-01, 79814-006-02

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
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
XYLITOLVCQ006KQ1EIACT
STEVIOSIDE0YON5MXJ9PIACT
FD&C RED NO. 40WZB9127XOAIACT
LEVOMENTHOLBZ1R15MTK7IACT
CITRUS PARADISI SEED12F08874Y7IACT
PROPOLIS WAX6Y8XYV2NOFIACT
ALOEV5VD430YW9IACT
EUCALYPTUS OIL2R04ONI662IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIB
SODIUM PYROPHOSPHATEO352864B8ZACTIB

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
afdacfbb-a6dc-2419-e053-2a95a90a79de2c74e751-6c66-473a-aece-38d83fd47c482020-09-21WarningsExact identifier
spl id: afdacfbb-a6dc-2419-e053-2a95a90a79de
spl set id: 2c74e751-6c66-473a-aece-38d83fd47c48

Reported adverse events (FAERS/openFDA)#

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