Otc - Active Ingredient
Active ingredient(s)
Silica 15.0%
Sodium Fluoride 0.22%
Tocopheryl Acetate 0.20%
Denti Buongiorno Gum Care Cool Mint Tooth Paste, Dentifrice
FDA Label NDC 73242-1127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dong Il Pharms Co.,ltd for the product Denti Buongiorno Gum Care Cool Mint Tooth (NDC 73242-1127). 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, warnings, otc - keep out of reach of children, indications & usage, 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
Antiplaque, Anticavity, Antigingivitis
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
Keep out of reach of childrenunder 6 years of age.
Indications & Usage
Use(s)
• Helps remove plaque and tartar buildup
• Helps prevent cavities
• Helps reduce gum inflammation and promote healthy teeth
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
• Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• Children under 2 years : Ask a dentist or physician
Other Safety Information
Other Information
• Store at temperatures between 1°C and 30°C
• Use within 36 months from the date of manufacture
• Do not store in high/low temperatures or direct sunlight
Otc - Questions
Questions
+82-1588-9709
Inactive Ingredient
Inactive ingredients
D-Sorbitol Solution , Water(Aqua) , Silicon Dioxide, Concentrated Glycerin, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Sodium Fluoride, Tocopherol Acetate, Sodium Bicarbonate, Hydrolyzed Collagen, Xylitol, Enzymatically Modified Stevia, Propolis Extract, Grapefruit Seed Extract, Aloe Extract, Matricaria Extract, Eucalyptus Extract, Sage Extract, Green Tea Extract, Rosemary Extract, Calendula Extract, Leontopodium Alpinum Extract, Centella Extract, L-Menthol, Peppermint Oil, Cool-Mint Flavor, Aqua Mint Flavor, Sodium Lauroyl Sarcosinate
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