Wellpatch Warming Pain Relief Patch
FDA Label NDC 10742-8127

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 Warming Pain Relief (NDC 10742-8127). 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, stop use and ask a doctor if, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsaicin 0.025%

Purpose

Capsaicin - 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

  • use only as directed
  • do not use at least 1 hours before, or immediately after, a bath or shower
  • 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
  • symptoms persist for more than 7 days or 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
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Inactive Ingredients

carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol monocaprylate, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, talc, tartaric acid

Questions Or Comments?

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Wellpatch Warming Pain Relief Patch (Image 01)

Wellpatch Warming Pain Relief Patch (Image 01)

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