Pain Relieving Patch Ultra Strength
FDA Label NDC 59779-991

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Pain Relieving Patch Ultra Strength (NDC 59779-991). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient
Menthol 5%

Otc - Purpose

Purpose

Topical Analgesic

Indications & Usage

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use if you

  • have redness over the affected area
  • are pregnant or breastfeeding

Otc - When Using

When using this product

  • avoid contact with eyes and mucous membranes
  • do not bandage tightly
  • do not use with a heating pad or other heating device

Otc - Stop Use

Stop using this product if

  • condition worsens
  • excessive skin irritation occurs
  • redness is present
  • symptoms persist more than 7 days or clear up and occur again within a few days
    • If pregnant or breastfeeding consult a healthcare professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily
  • children under 12 years of age consult a doctor
  • For best results, please ensure that the skin is clean and dry before applying
  • reseal pouch

Inactive Ingredient

Inactive Ingredients BHT, castor oil, cellulose gum, disodium edetate, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polyethylene, Non-Woven Material: polyester non-woven fabric.

Otc - Questions

Questions? Call toll-free 1-800-645-3867

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