Cavity Protection Fresh Mint Paste, Dentifrice
FDA Label NDC 63615-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oxyfresh Worldwide Inc for the product Cavity Protection Fresh Mint (NDC 63615-000). 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, purpose, uses, warnings, keep out of reach of children, do not use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.235%

Purpose

Anticavity paste

Uses

Helps protect against cavities.

Warnings

For topical application only. Do not swallow.

Keep Out Of Reach Of Children

under six years of age.  

  • Not to be used by children under six, unless recommended by a dentist or physician.
  • If paste is accidentally swallowed, contact a physician or Poison Control Center right away.

Do Not Use

if safety seal is torn or missing.

Directions

Apply a pearl-size drop onto a toothbrush. Gently brush teeth in a circular motion for 2-3 minutes after each meal.

Other Information

Store away from direct sunlight.

Ingredients

Sorbitol, Hydrated Silica, Glycerin, Water (Aqua), Sodium Lauryl Sulfate, Chondrus Crispus (Carrageenan), Stabilized Chlorine Dioxide (Oxygene), Sucralose, Zinc Acetate, Titanium Dioxide, Flavor*. Peppermint oil

* Please review the disclaimer below.