Biomin Restore Plus
FDA Label NDC 77055-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Drcollins, Inc. for the product Biomin Restore Plus (NDC 77055-100). 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 purpose, indications for use, instructions for use, warnings and precautions, keep out of reach of children, warning, active ingredient, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Purpose

→ Indications For Use

→ Instructions For Use

→ Warnings And Precautions

→ Keep Out Of Reach Of Children

→ Warning

→ Active Ingredient

→ Inactive Ingredients

→ Dosage & Administration

→ Storage & Handling

→ Carton

→ Tube Label

Purpose

Anticavity & Sensitivity Relief

Indications For Use

Fluoride dentifrice for use in the prevention and treatment of dental sensitivity.

Instructions For Use

Remove foil cover from nozzle, do not use if this seal has been broken. Brush twice daily for 2 minutes, ideally first thing in the morning and last thing at night, swirl the foamy dentifrice around your mouth for 30 seconds, and spit out. Do not swallow. Avoid rinsing your mouth
with water after brushing. Replace cap after use to keep dentifrice dry.

Warnings And Precautions

Continued tooth pain or sensitivivity could indicate an inherent problem that needs professional diagnosis. If symptoms persist consult your dentist. If irritation occurs, discontinue use.