FDA.reportPublic FDA data

Osstem G Gum Health Care Toothpaste

Manufacturer
Osstem Pharma Co., Ltd | DONG IL PHARMS CO., LTD.
Effective date
2026-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-29 01:02:03

Label at a glance#

ProductOsstem G Gum Health Care Tooth
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Sodium Fluoride 0.22%

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Uses

Aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

Keep out of 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

DOSAGE & ADMINISTRATION SECTION

Directions

■ Adults and children 2 years of age and older : Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) ■ Supervise children as necessary until capable of using without supervision.

■ Children under 2 years : Consult a dentist or doctor.

OTHER SAFETY INFORMATION

Other Information

Store at 1~30°C (34~86°F)

OTC - QUESTIONS SECTION

Questions

+82-1660-0675

info@osstempharma.com

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sorbitol, Silica, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, PEG-32, Menthol, Potassium Acesulfame, Tocopheryl Acetate, Xylitol, Panthenol, Centella Asiatica Extract, Citral, d-Limonene, Linalool

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Osstem G Gum Health Care Toothpaste

Carton imageCarton image

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809500573012GTIN-13: 8809500573012
EAN-13: 8809500573012
GTIN storage (14 digits): 08809500573012		gum care revised carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87548-02087548-020-01, 87548-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
PEG-321212Z7S33AIACT
LINALOOLD81QY6I88EIACT
CELLULOSE GUMK679OBS311IACT
XYLITOLVCQ006KQ1EIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POTASSIUM ACESULFAME23OV73Q5G9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
CITRALT7EU0O9VPPIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-04-15full-release2026-06-01 01:53:56

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
4f8b4fc0-4c99-5e52-e063-6394a90af7104f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
spl set id: 4f8b4fc0-4c98-5e52-e063-6394a90af710

Reported adverse events (FAERS/openFDA)#

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