Braline Patch

Read the patient information sheet provided before you start using this medication and each time you get a refill. If you have any questions, please consult your doctor or pharmacist. Inform your doctor if your condition does not improve or if it worsens.

This information may not include all the information needed to use BRALINE safely and effectively.

For Topical Use Only

What is BRALINE?

This is a topical, transdermal patch consisting of the topical analgesic, menthol, and the local anesthetic lidocaine HCL.

What is BRALINE used for?

The patch is applied to the skin assisting patients in the management of mild to moderate acute or moderate aches or pain. The diagnosis of acute or chronic topical pain can be made relatively simply by the diagnostic practitioner, however discovering the underlying pathology manifesting as pain and discomfort is much more difficult. The combination of lidocaine and menthol is a highly effective combination of pain relievers working synergistically to ameliorate the discomfort while the root cause is being managed and treated by your healthcare team.

Tell you healthcare provider if you:

• are allergic to menthol, lidocaine, local anesthetics, or any of the inactive ingredients listed in this insert.
• have a history of difficultly breathing, swelling of the tongue, or other allergic-type reactions after using menthol,

lidocaine, or other topical anesthetic.

• develop an undiagnosed rash following administration.
• are breastfeeding. It is unknown if the p atch passes to the milk.

What are the possible side effects of BRALINE?

• Common ( (≥10%): itching, redness or flaking of the skin following application (note: the majority of patients experience no significant adverse events following patch application).
• NOTE: 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 you 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 CNS effects such as dizziness, confusion, lightheadedness and orthostatic hypotension.

Call your healthcare provider right away it you get any of the follwing warning signs or any other unusual symptoms that concern you:

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

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

DIRECTIONS FOR USE

This patch is recommended for use in patients ages 12 and older.

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 get to them.
2. Remove the transparent release liner (clear plastic backing) before application of patches to the skin. Apply immediately after removal from the protective envelope.
3. Apply 1 patch to the affected area so that the patch covers most of the painful area. Apply patch only once during each 24-hr period.
4. Remove patch if irritation occurs.

General information about the safe and effective use

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication. Your doctor has prescribed this drug for you and you alone. Do not give this drug to anyone else, even if they have the same condition.

How should I store BRALINE?

Store product at room temperature at 68ºF to 77ºF (20ºC to 25ºC). Keep away from heat or sunlight. Protect from excessive moisture. Discard product after expiration date posted on the product label.

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

KEEP OUT OF REACH OF CHILDREN

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

What are the active ingredients in BRALINE?

The patch consists of 4% menthol and 4% lidocaine.

INACTIVE INGREDIENTS:

Water

Aloe Barbadesis Leaf (Aloe Vera Gel)

Glycerin EDT A Disodium Salt

Sodium Polyacrylate Diazolidinyl Urea

Methylparaben

Polysorbate 80

Propylparaben

Iodoproynyl Butylcarbarnate

CItrus Medica Limonum

(Lemon) Peel Oil

BRALINE (Menthol 4% / Lidocaine HCl 4% Transdermal Patch)

DESCRIPTION:

BRALINE is a prescription transdermal patch containing 10 articulated patches (5 per resealable pouch x 2 pouches). Lidocaine HCl is present in a 4% concentration (w/w). It is chemically designated as 2-(diethylamine)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula C 14H 22N 2O.

The molecular weight of lidocaine HCl is 234.34 g/mol. Menthol is present in a 4% concentration (w/w). The chemical name (1R,2S,5R)-2-isopropyl-5-methylcyclohexanol. The empirical formulat is menthol is C 10H 20O with a molecular weight of 156.27 g/mol.

The structural formulas are:

Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.

Because of the possiblility of sedation, patients should be cautioned regarding the operation of serious machinery or automobiles, and activities made hazardous by decreased alertness.

The safety of BRALINE has not been established during pregnancy. There are not well-controlled studies in pregnant women.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this drug is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Braline Patch may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.