Active Ingredient
Active ingredient: Sodium Monofluorophosphate 0.76%
Finefra Silver
FDA Label NDC 69653-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jewoo Medical Co,.ltd for the product Finefra Silver (NDC 69653-020). 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 active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients: Silica, Dental type silica, 6-Aminocaproic Acid, Allantoine Chlorohydroxy Aluminum, Glycerin, Polyethylene Glycol 1500, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Xylitol, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, L-Menthol, Peppermint Oil, Carvone, Anethole, Silver, Mica, CI 42090, Purified Water
Purpose
Purpose : Anticavity
Warnings
Warnings: 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: Keep out of the reach of children under 6 years of age.
Indications & Usage
Indications & usage: help protect against gum disease and cavities.
Dosage & Administration
Dosage & administration: 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.
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