FDA Label for Topcare Pain Relief Patch

Active Ingredients

Lidocaine 4%

Menthol 1%

Purposes

Topical anesthetic

Topical analgesic

Use

for the temporary relief of pain

Warnings

For external use only

Do Not Use

• more than 1 patch on your body at a time
• On cut, irritated, or swollen skin
• on puncture wounds
• For more than one week without consulting a doctor
• If you are allergic to any active or inactive ingredients
• if pouch is damaged or opened

When Using This Product

• use only as directed
• Read and follow all directions and warnings on this carton
• Do not allow contact with the eyes
• Do not use at the same time as other topical analgesics
• Do not bandage tightly or apply local heat (such as heating pads) to the area of use
• Do not microwave
• dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use And Ask A Doctor If

• condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children And Pets.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Directions

adults and children 12 years of age and over:

• clean and dry affected area
• carefully remove backing from patch starting at a corner.
• Appli sticky side of patch to affected area.
• Use one patch for up to 12 hours
• Dispatch patch after a single use.
• children under 12 years of age: consult a physician

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water.