Otc - Active Ingredient
Active ingredients
Sodium Fluoride 0.22%
Osstem G Gum Health Care Tooth Paste, Dentifrice
FDA Label NDC 87548-020
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 G Gum Health Care Tooth (NDC 87548-020). 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
Anticavity
Indications & Usage
Uses
Aids in the prevention of dental cavities
Warnings
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
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Dosage & Administration
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
Inactive Ingredient
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
* Please review the disclaimer below.
