OSSTEM S SENSITIVITY RELIEF TOOTH- potassium nitrate, sodium fluoride paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Potassium Nitrate 5.000%

Sodium Fluoride 0.221%

PURPOSE

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE

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

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.

KEEP OUT OF REACH OF CHILDREN

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

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)

QUESTIONS

Questions?

+82-1660-0675

info@osstempharma.com

INACTIVE INGREDIENT

Inactive ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, Sodium Lauryl Sulfate, PEG-32, Cellulose Gum, Hydroxyapatite, Xylitol, Menthol, Potassium Acesulfame, Titanium Dioxide,d-Limonene

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OSSTEM S SENSITIVITY RELIEF TOOTH 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87548-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.221 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
CELLULOSE GUM (UNII: K679OBS311)
HYDROXYAPATITE (UNII: 91D9GV0Z28)
POTASSIUM ACESULFAME (UNII: 23OV73Q5G9)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
PEG-32 (UNII: 1212Z7S33A)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87548-010-02	1 in 1 CARTON	04/01/2026
1	NDC: 87548-010-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	04/01/2026

Labeler - Osstem Pharma Co., Ltd (696467325)

Registrant - Osstem Pharma Co., Ltd (696467325)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(87548-010)