Each tub contains 10 grams of 10% numbing cream for effective pain relief.

Lidocaine 7%, Benzocaine 2%, Tetracaine 1%

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common questions about NUMBD 10% Cream. It does not contain all the available information and does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child using NUMBD against the benefits they expect it will have for you. If you have any concerns about this medicine, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again.

What is NUMBD used for?

NUMBD is a mixture of three local anaesthetics: lidocaine, benzocaine, and tetracaine. These local anaesthetics are combined with a special agent, VersaPro Cream base, which allows the products to pass through the skin. Once through the skin, the numbing effect they produce allows minor surgical procedures to be performed with a complete or significant reduction in pain. These procedures can include taking blood samples, vaccination, skin grafting and minor superficial cosmetic procedures. NUMBD is available as a cream which is applied and then covered with a dressing. Follow all directions given to you by your doctor/pharmacist carefully. They may differ from the information contained in this leaflet. Your doctor or pharmacist may prescribe this medicine for another use. Ask your doctor or pharmacist if you want more information. NUMBD is not addictive.

Before you use NUMBD:

When you must not use this product:

• Do not apply NUMBD cream to any open wounds.
• Do not use NUMBD if you are pregnant or breastfeeding unless your doctor says it is safe.
• Do not use after the use-by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
• Do not use it to treat any other complaints unless your doctor says it is safe.
• Do not give this medicine to anyone else.

Before you start to use it:

Tell your doctor or pharmacist if you or your child have:

1. Allergies to any of the ingredients listed at the end of this leaflet, local anaesthetics (for example those used at the dentist), adhesives, or sticking plasters. An allergic reaction may cause a skin rash, hay fever, or an asthma attack.
2. Any of these medical conditions: dermatitis, methaemoglobinaemia, glucose-6- phosphate dehydrogenase deficiency, mollusca contagiosa. It may not be safe for you or your child to use NUMBD if you have any of these conditions.

Taking other medicines:

Tell your doctor or pharmacist if you are using any other medicines, including:

• A sulphonamide antibiotic (e.g., sulfatrimoxazole)
• Medicines used to treat irregular heartbeat.
• Medicines that you buy at your pharmacy, supermarket, or health food shop
• Other local anaesthetics

These medicines may affect the way NUMBD works or may cause adverse effects. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

How to use NUMBD:

NUMBD is available as a cream. Instructions on how to use NUMBD are included in this document. Please read them carefully. The instructions also give maximum doses for adults and children. Do not exceed the maximum doses.

• On intact skin: Apply NUMBD at least one hour before your procedure is due.
• For superficial surgical and cosmetic procedures: to be applied a minimum of 1 hour prior to procedure and for a maximum of 5hrs. - Small areas: Apply 1.5g to 2g over a 10cm2 area of skin - Larger areas: Use a maximum of 60g over a 600cm2 area of skin.
• If you forget to use it, apply NUMBD as soon as you realise it is less than an hour until you are supposed to have the procedure. Tell your doctor exactly when you put NUMBD on, and they will decide when the procedure can take place. If you have trouble remembering when to use your medicines, ask your pharmacist for some hints.
• Once cream is applied to intended area(s) please cover with occlusive dressing.

If you take too much (overdose):

Telephone your doctor or Poisons Information Centre (13 11 26), or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have used too much NUMBD, even if there are no signs of discomfort or poisoning. For most procedures, it is difficult to use too much NUMBD. Be careful not to use too much in procedures where larger amounts may be required, such as cosmetic hair removal or tattoo procedure. Using too much NUMBD may cause unwanted side effects. Some of these can be serious, such as methaemoglobinaemia (a condition where the blood cannot take enough oxygen to your blood) or cardiovascular effects (effects on your heart and lungs). If you use too much NUMBD, you may notice the following:

• Nervousness
• Dizziness
• Difficulty breathing
• Numbness of the mouth
• Your skin turning blue (a symptom of methaemoglobinaemia)
• Blurred vision
• Shaky hands
• A rash where NUMBD has not been applied

If any of these occur or affect you-discontinue use immediately and seek medical attention.

While you are using NUMBD:

Things you must not do:
• Remember to apply NUMBD on intact skin at least one hour before your procedure is due.

Things to be careful of:

• Be sure to follow the instructions on how to apply NUMBD cream carefully.
• Make sure the dressing covering the cream is firmly fixed.
• Be careful not to let NUMBD get into the eyes. It may cause eye irritation. If NUMBD does get into your eyes, immediately rinse them with large amounts of water and contact your doctor or pharmacist for advice.

Side effects:

Tell your doctor or pharmacist as soon as possible if you do not feel well while using NUMBD. NUMBD helps most people to undergo minor procedures without feeling pain, but it may have unwanted side effects in a few people. All medicines have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you or your child get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• Any local reaction such as itching, swelling, paleness, redness, or a burning sensation.

These are all mild side effects of NUMBD. If any of the following happens, remove NUMBD and tell your doctor immediately or go to the closest emergency department:

• A rash at a spot where NUMBD is not being used.
• Difficulty breathing
• Dizziness
• Shaky hands
• Blurred vision
• Areas of skin becoming blue

These are very serious side effects. If you or your child have them, you or your child may have had a serious reaction to NUMBD and urgent medical attention or hospitalisation may be required. All of these side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you or your child feel unwell. Some people may get other side effects.

After using NUMBD - Storage:

• Keep your cream in the pack until it is time to use it. Before apply NUMBD wash hands thoroughly and ensure they are dry prior to application.
• Keep NUMBD in a cool, dry place where the temperature stays below 30°C. Do not let it freeze.
• Do not store NUMBD or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
• Keep it where young children cannot reach it. A locked cupboard one-and-a-half metres above the ground is a good place to store medicines.

Disposal:

• Ask your pharmacist what to do with any NUMBD you have left over if your doctor tells you to stop using it or you find that it has expired or no longer have use for it.

Shelf life:

• Do not use NUMBD after the expiry date printed on the pack. If you use it after the expiry date has passed, it may not work as well.

Product description - NUMBD cream contains:

• Lidocaine 7%
• Benzocaine 2%
• Tetracaine 1%
• VersaPro Cream base (Medisca proprietary product)

For further information:

This is not all the information that is available for NUMBD. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Manufacturer:

PandA Custom Compounding

1/7-9 Gawler St, Salisbury SA 5108, Australia.
Fulham Gardens: 08 8356 4131 Salisbury: 08 8281 7288