Cavity Protection Fresh Mint Anticavity Mouthwash
FDA Label NDC 63615-001

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 Anticavity Mouthwash (NDC 63615-001). 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 drug facts, active ingredient, purpose, uses, warnings, keep out of reach of children, do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Sodium fluoride 0.05%

Purpose

Anticavity rinse

Uses

Helps protect against cavities.

Warnings

For rinsing 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 more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away.

Do Not Use

if safety seal is torn or missing.

Directions

Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.

Other Information

Store away from direct sunlight.

Ingredients

Water (Aqua), Xylitol, Sodium Benzoate, Potassium Phosphate, Flavor*, Stabilized Chlorine Dioxide (Oxygene), Sodium Hydroxide, Citric Acid.

*Contains Peppermint Essential Oil

Package Labeling:3.8 L

Label (Label)

Label (Label)

* Please review the disclaimer below.