Lidocaine, Menthol, and Methyl Salicylate
Drug Details
- Generic Name
- Lidocaine, Menthol, and Methyl Salicylate
- Brand Names
- LidoPro Patch
- Application Number
- M017
- Sponsor
- Quality Care Products, LLC
- NDC Codes
- 4
- Dosage Forms
- PATCH
- Routes
- TOPICAL
- Active Ingredients
- LIDOCAINE HYDROCHLORIDE, MENTHOL, METHYL SALICYLATE, LIDOCAINE, MENTHOL, UNSPECIFIED FORM
Indications and Usage
Uses Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: • muscle soreness • strains • sprains • arthritis • simple backache • muscle stiffness • bruises
Warnings
Warnings For external use only Stomach bleeding warning This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others) • take a blood thinning (anticoagulant) or steroid drug • have three or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do not use • on the face or rashes; on wounds or damaged skin • in the eyes, mouth, or other mucous membranes • on genitals • with a heating pad • if allergic to any NSAIDS • right before or after heart surgery • any patch from a pouch that has been opened for 7 or more days Ask a doctor before use if • you are allergic to topical products • the stomach bleeding warning applies to you • you are taking a diuretic • you have high blood pressure, heart disease, or kidney disease • you are pregnant When using this product • wash hands after applying or removing patch • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and consult your physician if • stomach pain or upset gets worse or lasts • rash, irritation, or itching develops • you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding) • condition worsens If pregnant or breast feeding, ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.
Stomach bleeding warning This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others) • take a blood thinning (anticoagulant) or steroid drug • have three or more alcoholic drinks every day while using this product • take more or for a longer time than directed