Osstem S Sensitivity Relief Toothpaste

Manufacturer
Osstem Pharma Co., Ltd | DONG IL PHARMS CO., LTD.
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:54:22

Label at a glance#

ProductOsstem S Sensitivity relief tooth
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Potassium Nitrate 5.000%

Sodium Fluoride 0.221%

OTC - PURPOSE SECTION

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

Uses

■ Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

■ Aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Do not use this product longer than 4 weeks unless recommended by a dentist or a doctor.

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

■ Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor.

■ Make sure to brush all sensitive areas of the teeth.

■ 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 12 years of age: 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, Hydrated Silica, Water, Glycerin, Sodium Lauryl Sulfate, PEG-32, Cellulose Gum, Hydroxyapatite, Xylitol, Menthol, Potassium Acesulfame, Titanium Dioxide,d-Limonene

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2741131potassium nitrate 5 % / sodium fluoride 0.221 % (fluoride ion 0.10 % ) ToothpastePSN1
2741131potassium nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG ToothpasteSCD1
2741131K+ nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG ToothpasteSY1
2741131Pot nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG ToothpasteSY1
2741131potassium nitrate 5 % / sodium fluoride 0.221 % (fluoride ion 0.10 % ) ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809500573005GTIN-13: 8809500573005
EAN-13: 8809500573005
GTIN storage (14 digits): 08809500573005
sensitive carton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87548-010-01Osstem S Sensitivity relief tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
87548-010-02Osstem S Sensitivity relief tooth1 in 1 CARTONPASTE, DENTIFRICE11

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
87548-01087548-010-01, 87548-010-02

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
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
ndc (package): 87548-010-01
ndc (package): 87548-010-02
ndc (product): 87548-010
ndc11 (package): 87548001002
ndc11 (package): 87548001001
spl id: 4f8ab179-8f2a-a7cf-e063-6294a90a0c22
spl set id: 4f8ab179-8f29-a7cf-e063-6294a90a0c22

Reported adverse events (FAERS/openFDA)#

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