Camphor (Synthetic), Menthol, Unspecified Form, and Methyl Salicylate

FDA Drug Profile — Leader Ultra Strength Muscle Rub Topical Analgesic

Drug Details

Generic Name
Camphor (Synthetic), Menthol, Unspecified Form, and Methyl Salicylate
Brand Names
Leader Ultra Strength Muscle Rub Topical Analgesic
Application Number
M017
Sponsor
Cardinal Health, 110 dba LEADER
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE

Indications and Usage

Uses for the temporary relief of minor aches and muscles and joints associated with: arthritis simple backache strains sprains

Warnings

Warnings For external use only Do not use with a heating pad on wounds, damaged, broken or irritated skin on a child under 12 years of age with arthritis-like conditions Ask a doctor before use if you have redness over the affected area When using this product use only as directed do not swallow do not bandage tightly avoid contact with the eyes and mucous membranes Stop use and consult a doctor if skin redness or irritation develops condition worsens or pain lasts for more than 7 days symptoms clear up and occur again within a few days Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.