Active Ingredient
Active ingredients: Sodium monofluorophosphate 0.74%
The following Structured Product Label (SPL) was submitted to the FDA by Sgs Inc. for the product Plus153 Toothpast E (NDC 71553-010). 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, uses, directions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients: Sodium monofluorophosphate 0.74%
Inactive ingredients: Silica, Aminocaproic Acid, Allantoine Chlorohydroxy Aluminum, PEG-1500, D-Sorbitol, Glycerin, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Xylitol, Sodium Saccharin, Sophora Angustifolia Root Extract, Glycyrrhiza Glabra Root Extract, Sodium Benzoate, L-Menthol, Carvone, Anethole, Peppermint Oil, Silver, Water
Purpose: Anticavity
Warnings: For external use only If more than used for brushing is accidently swallowed get medical help or contact a poison control center immediately Avoid contact with eyes.
Keep out of reach of children under 6 years of age.
Uses: Helps protect against cavities.
Directions:
Supervise children as necessary until capable of using without supervision.
- Adults and children 6 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 a physician
- children under 12 years: instruct in good brushing and rinsing habits (to minimize swallowing)
- children under 6 years: do not use unless directed by a dentist or a physician
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