SPL Medguide

Lidothol (Lidocaine 4.5% / Menthol 5% Patch)

For Topical Use Only

Do not use:

• On the face or rashes
• On wounds, damaged, or infected skin
• In the eyes, mouth or other mucous membranes
• On genitals
• With a heating pad

Ask a doctor before use if:

• You are allergic to topical products or any ingredients in this product
• You are pregnant or breast feeding
• You are under age 18

When using this product:

• Wash hands after applying or removing patch
• Avoid contact with eyes
• If eye contact occurs, rinse thoroughly with water

Stop use and consult your physician if:

• Rash, irritation, or itching develops
• Condition worsens Keep out of reach of children

Lidothol Patient Information.

Before you begin using this medication: read this entire patient information sheet. If you have any questions, please consult your physician or pharmacist. Inform your physician if your condition does not improve or if it worsens.

This information may not include all of the details needed to use Lidothol safely and effectively. Discuss use with your doctor or pharmacist.

What is Lidothol?

A topical pain relief patch consisting of the local anesthetic Lidocaine (4.5%) and the topical analgesic Menthol (5%).

What is Lidothol used for?

The patch assists patients in the management of mild to moderate acute pain or mild to moderate aches. Lidothol is applied to the skin at the specific region experiencing these pain symptoms. The synthesis of Lidocaine and Menthol is a highly effective combination of pain relievers working to alleviate discomfort while the root cause is being managed and treated by your healthcare providers.

DO NOT USE:

• If you are allergic to any of the ingredients in this product
• On wounds or damaged skin
• With a heating pad
• If you are pregnant, planning to become pregnant, or breastfeeding

What are the possible side effects with Lidothol?

• Common: itching or redness of the skin following application
• NOTE: The majority of patients experience no significant adverse events following patch application. Serious side effects, are, in general, related to accidental toxicity of medication by applying considerably more than directed by your doctor or pharmacist or by ingesting the contents of the patch.
• Tell your healthcare provider about all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements.
• Avoid excessive alcohol usage, since it may increase the potential for Central Nervous System (CNS) effects such as dizziness, confusion, lightheadedness and orthostatic hypotension.

This is not a complete list of the possible side effects. For more information, talk with your doctor or pharmacist. You may report side effects to FDA at 1-­‐800-­‐FDA-­‐1088 or www.fda.gov/medwatch

KEEP OUT OF REACH OF CHILDREN Rx ONLY

DIRECTIONS FOR USE

Adults and children 12 years and over:

Apply 1 to 2 patches to the affected area of intact skin. Lidothol should be removed after 12 hours of continuous use and remain off for at least 12 hours.

1. Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors. Safely discard the remaining unused pieces of cut patches where children and pets cannot reach.
2. Remove the transparent protective film (clear plastic barrier) before application of patches to the skin. Apply immediately after removing the protective film.
3. Apply 1 patch to the affected area so that the patch covers all or most of the painful area.
4. Remove patch if irritation occurs.

Children under 12 years of age: Consult a doctor

WARNINGS

1. Do not use:
2. On wounds, cuts, damaged or infected skin
3. On eyes, mouth, genitals, or other mucous membranes

2. Consult physician for children under 12 years of age

3. Stop and consult your prescriber if pain worsens

Call your healthcare provider right away if you experience any of the following warning signs or any other unusual symptoms of concern:

• Shortness of breath
• Swelling or numbness of the tongue or throat
• Severe headache or vomiting
• Dizziness or faintness
• Changes in vision or speech

General information for safe and effective use of Lidothol

Do not use this product for another indication. Do not give this drug to anyone else, even if they have the same condition. This product is intended for use as prescribed by a physician.

How should I store Lidothol?

Store product at room temperature at 65˚F to 75˚F (18˚C to 24˚C). Keep away from heat or sunlight. Protect from excessive moisture. Safely discard product after expiration date posted on the product label. Discard patches away from small children or animals.

DO NOT use the product after the expiration date printed on the box.

This insert provides the most important information about Lidothol. If you would like more information, talk with your healthcare provider or pharmacist. There is additional information in the following sections intended for healthcare professionals.

What are the active ingredients in Lidothol?

The patch consists of 4.5% Lidocaine and 5% Menthol.

What are the inactive Ingredients in Lidothol?

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