Otc - Active Ingredient
Active ingredients
Potassium Nitrate 5.000%
Sodium Fluoride 0.221%
Osstem S Sensitivity Relief Tooth Paste, Dentifrice
FDA Label NDC 87548-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Osstem Pharma Co., Ltd for the product Osstem S Sensitivity Relief Tooth (NDC 87548-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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)
Otc - Questions
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
* Please review the disclaimer below.
