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Generic: lidocaine, menthol is used for the treatment of Adams-Stokes Syndrome Burns Esophageal Diseases Hypersensitivity Mouth Diseases Pain Tachycardia, Paroxysmal Ventricular Fibrillation Tachycardia, Ventricular Ventricular Premature Complexes Drug-Related Side Effects and Adverse Reactions Skin Diseases

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Otc - Active Ingredient Section


Active Ingredients (in each patch):

Lidocaine 4.5% Topical Anesthetic

Menthol 5% Topical Analgesic

Otc - Purpose Section


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 Section


WARNINGS:

For external use only

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 steroidal 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 NSAID’s
  • 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 takin 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.

Otc - Keep Out Of Reach Of Children Section


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.

Dosage & Administration Section


Adults, or children over the age of 12:

Apply patch to affected are 1 to 2 times daily or as directed

Children under 12 years of age:

Do not use

Indications & Usage Section


INSTRUCTIONS FOR USE:
  • Clean and dry affected area
  • Open pouch and remove one patch
  • Remove protective film from patch
  • Apply one patch to the affected area of pain and leave in place for 8 to 12 hours
  • If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
  • Only use one patch at a time
  • Do not use more than 2 patches per day
  • Wash hands with soup and water after applying or removing patch
  • Reseal pouch containing unused patches immediately after each use

Other Safety Information


OTHER INFORMATION:
  • Some individuals may not experience pain relief until several minutes or hours after applying the patch
  • Store in a cool, dry place
  • Protect product from excessive moisture or sunlight
  • Store at 67-77o F (19-25o C)

Inactive Ingredient Section


INACTIVE INGREDIENTS:

Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerine, Kaolin, Partially Neutralized Polyacrylate, Phenoxyethanol, Polysorbate 80, Polyvinyl Pyrrolidone, Tartaric Acid, Tetrasodium EDTA, Water

Package Label.principal Display Panel






DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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