Active Ingredients
Camphor 3.1%
Menthol 6%
Methyl Salicylate 10%
Healthwise 3x Medicated Pain Relief Patch 120 Bulk Patch
FDA Label NDC 71101-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise 3x Medicated Pain Relief Patch 120 Bulk (NDC 71101-032). 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, purposes, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Topical analgesic
Topical analgesic
Topical analgesic
Use
For 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.
Do Not Use
■More than one patch on your body at a time
■ On wounds or damaged skin
■ With a heating pad
■If you are allergic to any ingredients of this product.
When Using This Product
■Use only as directed and 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.
Stop Use And Ask 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.
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 a 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
* Please review the disclaimer below.
