FDA.reportPublic FDA data

DIVINETREE SSAK SHARK KIDS TOOTH

Manufacturer
K.biocos | Korea Life Science Co.,ltd
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:44

Label at a glance#

ProductDIVINETREE SSAK SHARK KIDS TOOTH
Active ingredientSILICON DIOXIDE, ALCLOXA
Label structure8 sections

Indications and uses

Uses: Brightens and Strengthens teeth Leaves the mouth clean and fresh Protects against gingivitis and paradentitis Protects against gum disease Removes Plaque

Dosage and administration

Directions: Recommended for ages 3years and older Apply a peas size amount on toothbrush and brush teeth thoroughly. Use at least twice a day preferably after each meal or as directed by a dentist or physician. Children should be supervised to minimize swallowing.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Silica 13.0%, Alcloxa 0.16%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Glycerin, Sorbitol, Cellulose Gum, Xylitol, Ascorbic Acid, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Salvia Officinalis (Sage) Leaf Extract, Calcium Glycerophosphate, Milk, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Calendula Officinalis Flower Extract, Streptococcus Thermophilus Ferment, Chamomilla Recutita (Matricaria) Flower Extract, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Flavor, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Water

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticavities, Anticarries

WARNINGS

WARNINGS SECTION

Warnings:

Keep out of the reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

Uses

INDICATIONS & USAGE SECTION

Uses:
Brightens and Strengthens teeth
Leaves the mouth clean and fresh
Protects against gingivitis and paradentitis
Protects against gum disease
Removes Plaque

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:
Recommended for ages 3years and older
Apply a peas size amount on toothbrush and brush teeth thoroughly. Use at least twice a day preferably after each meal or as directed by a dentist or physician.
Children should be supervised to minimize swallowing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809597413956GTIN-13: 8809597413956
EAN-13: 8809597413956
GTIN storage (14 digits): 08809597413956		ssak carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73494-010-022021-01-29C16284748780-1ba0f9c33-34a1-a910-e053-dadaa90a0b857ef2f4c1-1592-4064-8124-bfc18154858c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73494-010-01DIVINETREE SSAK SHARK KIDS TOOTH50 g in 1 TUBEPASTE, DENTIFRICE501
73494-010-02DIVINETREE SSAK SHARK KIDS TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73494-010DIVINETREE SSAK SHARK KIDS TOOTH (SILICON DIOXIDE, ALCLOXA) PASTE, DENTIFRICE [K.BIOCOS]1Legacy NDC, 2 package rows20191204_7ef2f4c1-1592-4064-8124-bfc18154858c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73494-01073494-010-01, 73494-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCLOXA18B8O9DQA2ACTIB
GlycerinPDC6A3C0OXIACT
SORBITOL506T60A25RIACT

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
2e6d3fb6-bd1f-4e1a-a24e-cdb31dbb1c207ef2f4c1-1592-4064-8124-bfc18154858c2019-12-04WarningsExact identifier
spl id: 2e6d3fb6-bd1f-4e1a-a24e-cdb31dbb1c20
spl set id: 7ef2f4c1-1592-4064-8124-bfc18154858c

Reported adverse events (FAERS/openFDA)#

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