Medline Peroxi Fresh Mouthwash
FDA Label NDC 53329-086

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Medline Peroxi Fresh (NDC 53329-086). 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, use, warnings, do not use this product, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Oral Debriding Agent

Use

  • Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

Warnings


Do Not Use This Product


  • for more than 7 days unless directed by a dentist or physician.

When Using This Product


  • do not swallow

Stop Use And Ask A Doctor If

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

Keep Out Of Reach Of Children

  • If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.

Directions

  • Adults and Children 2 Years of Age or Over: Swish around in mouth over affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
  • Children Under 12 Years of Age: Should be supervised in the use of this product.
  • Children Under 2 Years of Age: Consult a dentist or a doctor.

Other Information

  • Avoid excessive heat and protect from freezing.

Inactive Ingredients

Flavor, Sodium Lauryl Sulfate, Sodium Saccharin, Water.

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