This medication is a patch that contains 2 amide-type anesthetics for numbing a small area, lidocaine and prilocaine. It is used on normal, unbroken skin to prevent pain before certain procedures such as inserting a needle for injections or drawing blood. It is also used before certain vaccinations (measles/mumps/rubella-MMR, diphtheria/pertussis/tetanus/poliovirus-DPTP, H. influenzae b, hepatitis B). It works by temporarily numbing the skin and surrounding area.

This medication should not be used in premature infants (infants born before 37 weeks of pregnancy).

Read the Patient Information Leaflet if available from your pharmacist before you start using lidocaine/prilocaine disc and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Clean and dry the skin before applying the patch. Peel away the protective liner and place the disc on the procedure site as directed by your doctor, usually 1 hour before the procedure. Do not touch the white round part that contains the medication. Firmly press down on the edges of the patch to make sure it is well attached. Gently press on the center of the patch. Using a ballpoint pen, mark on the patch the time it was placed.

Remove the patch and clean the area thoroughly, usually shortly before the procedure or as directed by your doctor. The length of time for the medication to stay on the skin depends on your age and the type of procedure you are having. Do not leave it in place for longer than directed since the chance for side effects may be increased. Carefully fold the patch in half with the sticky sides together and discard out of reach of children and pets. Do not re-use the patch. Wash hands immediately after use unless you are treating an area on the hands.

This patch may be harmful if placed in the mouth or swallowed. If you are applying this product on a child, make sure the patch stays in place and that your child does not put the patch in his/her mouth. You may want to use a second covering to prevent the child from touching the patch.

Use this medication only on normal, intact skin. Do not use on open wounds/cuts/scrapes/burns/rashes (including diaper rash) or mucous membranes. Do not use this product in the ears or near the eyes. Avoid getting the product in your eyes, nose, ears, or mouth. If this medication gets in the eyes, rinse the affected eye right away and completely with water or saline. Numbness in the eye can lead to injury because you cannot feel particles in the eye or other dangers. Protect the eye until feeling returns.

The numbing effect should start within 1 hour. The area may be numb for several hours after removing the patch. Protect the area from injury. Be careful not to bump, rub, or scratch the area or expose it to heat/cold until feeling returns.

Redness, swelling, tingling, burning, or lightening of the skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• blistering of the skin where the patch is applied

Remove the patch and get medical help right away if you have any very serious side effects, including:

• slow/shallow breathing
• dizziness
• fainting
• fast/slow/irregular heartbeat
• mental/mood changes (such as confusion, nervousness)
• seizure
• severe drowsiness
• pale/bluish/gray skin
• unusual tiredness
• shortness of breath

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or prilocaine; or to any other amide anesthetics (such as bupivacaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain blood disorder (methemoglobinemia)
• heart disease (such as irregular heartbeat)
• kidney disease
• liver disease
• skin problems (such as infection, dermatitis, eczema)

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

Older adults may be more sensitive to the side effects of this drug, especially dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Lidocaine passes into breast milk. It is unknown if prilocaine passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: seizures, loss of consciousness.

Do not share this medication with others.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.