Plus153 Toothpast E
FDA Label NDC 71553-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 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 Ingredient

Active ingredients: Sodium monofluorophosphate 0.74%

Inactive Ingredient

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

Purpose: Anticavity

Warnings

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

Keep out of reach of children under 6 years of age.

Uses

Uses: Helps protect against cavities.

Directions

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

* Please review the disclaimer below.