Large Pain Relieving Patch
FDA Label NDC 0363-9904

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 Company for the product Large Pain Relieving (NDC 0363-9904). 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, inactive ingredienthydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer, keep out of reach of children, indications & usage, warnings, dosage & administration, if pregnant or breastfeeding, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active IngredientPurpose
Camphor 3.1% Topical Analgesic
Menthol 6.0% Topical Analgesic
Methyl Salicylate 10.0% Topical Analgesic

Inactive Ingredienthydrogenated Poly, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Petroleum, Styrene/Isoprene Copolymer

Keep Out Of Reach Of Children

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

Indications & Usage

For temporary relief of minor aches and pains of muscles and joins: arthritis, simple backache, muscle strains, muscle sprains and bruises.

Warnings

For External Use Only

Allergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.

Dosage & Administration

Adults and children over 12 years:

Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.

Do not use for more than 8 hours.

Discard patch after use.

Reseal pouch after opening.

Children under 12 years of age, consult a physician.

If Pregnant Or Breastfeeding

ask a health professional before use.

Purpose

Topical Analgesic

When Using This Product:

■ Use only as directed ■ Avoid contact with eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Do not use at the same time as other topical analgesics ■ Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.

Do Not Use

  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients in this product.

Stop Use And Consult A Doctor

  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • If symptoms last more than 7 days or clear up and occur again in a few days.

Storage And Care

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Pain Relieving Path

DIST. BY
Walgreens Co.
200 Wilmot Rd
. Deerfield, IL 60015
www.walgreens.com

TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313

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