Active Ingredients
Camphor 3.1% - Topical analgesic
Menthol 6.0% - Topical analgesic
Methyl Salicylate 10.0% - Topical analgesic
Pain Relief Patch
FDA Label NDC 83324-255
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cdma, Inc. for the product Pain Relief Patch (NDC 83324-255). 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, purpose, uses, warnings, directions, other information, inactive ingredients, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
Temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, muscle strains, muscle sprains, and bruises.
Warnings
For external use only.
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Directions
Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Remove patch from film, apply to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.
Children under 12 years of age: Consult a physician.
Other Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Inactive Ingredients
Hydrogenated poly
Pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate
Petroleum
Styrene/isoprene copolymer
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Stop Use
Stop use and consult a doctor if rash, itching or excessive skin irritation develops, condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.
Otc - Do Not Use
Do not use more than one patch on your body at a time, on wounds or damaged skin, with a heating pad, or if you are allergic to any ingredients of this product.
Otc - When Using
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.
* Please review the disclaimer below.
