Menthol Pain Relief Gel Patch
FDA Label NDC 55629-025

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Menthol Pain Relief Gel Patch (NDC 55629-025). 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:, when using this product:, stop use and ask a doctor if:, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 5%

Purpose

Topical Anesthetic

Use

Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache, arthritis, strains, bruises and sprains

Warnings

For external use only

Do Not Use:

  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds or damaged skin
  • for more than one week without consulting a doctor
  • with heating pad
  • on a child under 12 yeas of age with arthritis-like conditions

When Using This Product:

  • use only as directed.
  • read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type.
  • do not apply to wounds or damaged, broken or irritated skin
  • do not allow contact with eyes and mucous membranes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets
  • used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if a severe burning sensation occurs, discontinue use immediately.
  • discontinue use at least 1 hour before a bath or shower.
  • do not use immediately after a bath or shower.

Stop Use And Ask A Doctor If:

condition worsens

redness is present over the affected area

excess skin irritation occurs

symptoms persist for more than 7 days or clear up and occur again within a few days

you experience signs of skin injury such as pain, swelling, or blistering where the product was applied

Directions:

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
  • carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • do not wear a patch for more than 8 hours
  • apply affected area no more than 3 times daily
  • children 12 years or younger: ask a doctor

Other Information:

Store at room temperature 20-250C (68-770F)

Questions?  call toll-free 1-844-912-4012

Inactive Ingredients:

Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Paraffin

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