Pain Relieving Patch
FDA Label NDC 0363-0151

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Pain Relieving Patch (NDC 0363-0151). 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
If pregnant or breast-feeding, consult a healthcare professional before use

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • 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

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 devices

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • excessive skin irritation occurs
  • redness is present
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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

Storage And Handling

Other information

  • store at room temperature

Inactive Ingredient

Inactive ingredients

alumina magnesioum metasilicate, BHT, castor oil, cellulose gum, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide.

Otc - Questions

Questions or comments?

1-800-WALGREENS (1-800-925-4733)

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