Only for external use

Use only as directed by a health professional.

Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

Do not cover with bandages

Consult physician for childrn under 12

Consult your physician if pregnant or pain persists or worsens

Keep out of reach of children. Consult physician for children under 12.

PATIENT INFORMATION

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

PRESCIBER INFORMATION

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:

CLINICAL PHARMACOLOGY:

Lidocaine is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

Menthol has local anesthetic and counterirritant qualities, and it also acts as a weak kappa (k) opioid receptor agonist. Menthol acts to chemically trigger the cold-sensitive TRPM-8 receptors in the skin-responsible for the well-known cooling sensation it stimulates when applied directly to the skin. Menthol's analgesic properties are not fully understood, however they are mediated through a selective activation of k-opioid receptors. Menthol also blocks voltage-sensitive sodium channels, reducing neural activity that may stimulate muscle tissue.

INDICATIONS AND USAGE:

BRALINE is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact. If consulted by your physician, it may be used for other conditions as well.

CONTRAINDICATIONS:

Known hypersensitivity to menthol, lidocaine, or any of the topical amide-like anesthetic preparations.

WARNINGS:

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.

PRECAUTIONS:

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.

DRUG INTERACTIONS:

No Drug interactions have been assessed with BRALINE.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

Nonclinical toxicity studies to determine the potential of this topical preparation to cause carcinogenicity or mutagenicity have not been performed. The effect of the product on fertility has not been evaluated in animals.

PREGNANCY:

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

PEDIATRIC / GERIATRIC USE:

Safety and effectiveness in pediatric and geriatric patients have not been established.

NURSING MOTHERS:

The effect of BRALINE on the nursing infant has not been evaluated.

ADVERSE REACTIONS:

The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time.

Serious adverse experiences following the administration of BRALINE are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

OVERDOSAGE:

There have been no reports of over-dosage with BRALINE. Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institue supportive measures.

STORAGE:

Store at room temperature at 68ºF to 77ºF (20ºC to 25ºC). Keep away from heat or sunlight.

Protect from excessive moisture. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.

HOW SUPPLIED:

BRALINE is supplied in the following dosage form:

• 10 Articulated Patches [ (5 per Re-sealable Pouch) X 2]

Manufactured for: DocRX, Inc., Mobile, AL

PRODUCT PACKAGING: