Menthozen Hydrogel Patch
FDA Label NDC 71205-334

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Menthozen Hydrogel (NDC 71205-334). 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 ingredients:, otc - purpose, uses:, warnings:, do not use, keep out of reach of children., stop use and consult physician, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Menthol 4.00%

Capsaician 0.03%

Otc - Purpose

External Analgesic

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings:

For external use only. Use only as directed.

  • Avoid contact with eyes and mucous membranes.
  • Do not apply to open wounds or damaged skin.

Do Not Use

  • in combination with any external heat source.
  • Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.

Keep Out Of Reach Of Children.

  • Do not use if allergic to Menthol.

Stop Use And Consult Physician

  • if symptoms worsen or persist for more than 7 days.
  • Stop use if itching or excessive skin irritation occurs.

If Pregnant Or Breast Feeding,

  • contact physician prior to use

Directions:

Adults and children 12-years and over: Apply to affected area; change patch 1-2 times dily.

Children under 12, consult a physician before use.

How to Apply:

Remove patch from backing and apply directly to area of pain.

Do not apply to affected area more than three times daily.

Use only one patch at a time.

Wash hands with soap and water immediately after application.

Reseal pouch containg unused patches. 

Other Information:

Store below 25 degrees Celsius. Avoid direct sunlight.

Inactive Ingredients:

Aqua (Deionized Water), Sodium Polyacrylate, Glycerol, D-Glucitrol, Sodium Cellulose Glycolate, Polysorbate-80, Lemon Oil, Aluminum Glycinate, Methylparaben, EDTA Disodium Salt

Package Labeling:

71205-334-30 (Label)

71205-334-30 (Label)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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