Wellpatch Cooling Pain Relief Patch
FDA Label NDC 10742-8125

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Wellpatch Cooling Pain Relief (NDC 10742-8125). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., 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

Menthol - Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only

When Using This Product

  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad

Stop Use And Ask A Doctor If

  • condition worsens
  • excessive redness, irritation, burning, or discomfort of the skin develops
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
  • children under 12 years: ask a doctor
  • FOR BEST RESULTS apply to clean, dry skin
  • tear open pouch and remove patch; if desired, cut patch to size
  • grasp both ends of the patch firmly with thumbs near center
  • stretch patch until the backing separates
  • remove protective film while applying patch directly to site of pain

Inactive Ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexyl acrylate, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polymethyl acrylate, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid

Questions?

1-877-636-2677 MON - FRI 9AM to 5PM (EST)

www.wellpatch.com

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