Active Ingredient
Active Ingredient: Sodium Monofluorophosphate 0.76%
Alegria
FDA Label NDC 70406-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Seowangmo Corporation for the product Alegria (NDC 70406-010). 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 active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, use, directions, 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: D-Sorbitol Solution, Silicon Dioxide, Dentaltype silica, Polyethylene Glycol 1500, Glycerin, Sodium Lauryl Sulfate, Carboxymethylcellulose Sodium, Sodium Benzoate, Allantonie Chlorohydroxy Aluminum, Aminocaproic Acid, Xylitol, Saccharin Sodium Hydrate, Licorice Extract, Sophora Extract, Aloevera Gel, Peppermint Oil, L-Menthol, Anethole, Carvone, Mica, Silver foil, 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 reach of children under 6 years of age.
Use
Use: Aids in the prevention of dental cavities
Directions
Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.
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