The following Structured Product Label (SPL) was submitted to the FDA by Nanowell Korea Inc for the product Nano Silver Toothpaste (NDC 45163-451). 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, inactive ingredient, warnings, otc - keep out of reach of children, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active Ingredients: Colloidal Silicon Dioxide, Sodium Monofluorophosphate, Sodium Chloride, Glycerin
Inactive Ingredient
Inactive Ingredients: D-Sorbitol Solution, Polyethylene Glycol 1500, Hydrated Silica, Carboxymethylcellulose Sodium, Chitosan, Sodium Alginate, Tocopherol Acetate, Xylitol, Saccharin Sodium, Methyl Parahydroxybenzoate, Sodium Lauryl Sulfate, Argentum, Mentha Oil, L-Menthol, Purified Water
Warnings
Warnings: When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive tooth may indicate a serious problem that may need prompt care.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
Direction: adults and children 12 yrs and older. apply at least a half-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 3 minutes twice a day (morning and evening). under 12 yrs ask a dentist.
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