Methyl Salicylate, Camphor

FDA Drug Profile — elp essential MANTECA DE UBRE, Muscle Therapy

Drug Details

Generic Name
Methyl Salicylate, Camphor
Brand Names
elp essential MANTECA DE UBRE, Muscle Therapy
Application Number
M017
Sponsor
Miramar Cosmetics, Inc DBA Miramar Lab
NDC Codes
2
Dosage Forms
OINTMENT, SALVE
Routes
TOPICAL
Active Ingredients
CAMPHOR (NATURAL), 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