Pain Relief Medicated Patch
FDA Label NDC 11822-7883

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Pain Relief Medicated (NDC 11822-7883). 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 ingredient, 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 Ingredient

hydrogenated 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 12 years of age and over:

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
RITE AID Co.
30 Hunter Lane
Camp Hill, PA 17011
www.riteaid.com

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

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