Healthwise Pain Relief Patch
FDA Label NDC 71101-106

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 Patch (NDC 71101-106). 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, warnings, do not use:, when using this product, stop use and consult a doctor, keep out of reach of children, purpose, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Active Ingredients Purpose

Menthol 3.0% .......................External Analgesic

Methyl Salicylate 10.0%  .......External Analgesic

Warnings

For External Use Only

Do Not Use:

  •  on wounds or damaged skin ■ do not bandage tightly

When Using This Product

  •  avoid contact with eyes ■ Do not use more than one patch on your body at a time

Stop Use And Consult A Doctor

Stop use and ask a doctor if■ skin irritation develops ■ condition worsens ■ 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 (1-800-222-1222) right away. 

Purpose

External Analgesic

Directions

■Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 8 hour period. Maximum 3 patches per day. Discardpatch after single use.

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

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication And Usage

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
■ strains ■ sprains ■ simple backache ■ arthritis ■ bruises

* Please review the disclaimer below.