Menthol, Methyl Salicylate, Camphor

FDA Drug Profile — CVS Health Pain-Relieving Patch

Drug Details

Generic Name
Menthol, Methyl Salicylate, Camphor
Brand Names
CVS Health Pain-Relieving Patch
Application Number
M017
Sponsor
CVS Pharmacy, Inc.
NDC Codes
1
Dosage Forms
PATCH
Routes
TOPICAL
Active Ingredients
CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE

Indications and Usage

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.

Warnings

Warnings For external use only Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. 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 ■If you are allergic to any 1ngred1ents of this product 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. 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. If pregnant or breastfeeding ask a health professional before use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away