Healthwise Pain Relief Gel Patch
FDA Label NDC 71101-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Pain Relief Gel Patch (NDC 71101-105). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding, 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

Active Ingredients

Capsaicin: 0.025%

Menthol 1.25%

Purpose

External analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For External Use Only

When Using This Product

  • avoid contact with eyes
  • do not apply to wounds or damage skin
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • Conditions worsens
  • Symptons persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breastfeeding

ask a health professional before use

Keep Out Of Reach Of Children

if swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

Directions For Use:

Adults and Childrens 12 Years of Age and over: Clean and dry affected area, free of lotions, ointments and creams.  Carfully remove backing from patch.  Apply sticky side of patch to affected area.  Do not use more than one patch in an 8 hour period.  Repeat as necessary.  Maximum 3 patches per day.  Discard partch after single use. 

Children under 2 years of age:Do not use, ask a doctor

Inactive Ingredients:

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, penoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Questions

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