Topicaine^®

It is a non-oily, translucent gel containing Lidocaine 5% in a gel microemulsion with skin permeation enhancers and soothing agents.  It is a TOPICAL ANESTHETIC specially formulated to penetrate intact skin, for the relief of pain.

It is indicated for the relief of pain caused by:

• minor skin irritations
• minor burns
• minor cuts
• insect bites

In addition, medical aesthetic professionals use this product for medical aesthetic procedures (off label uses).  Check with your technician for your particular case and application.

Directions

APPLY A MODERATELY THICK LAYER, APPROX. 1\8 INCH THICK

ALLOW TIME FOR NUMBNESS TO DEVELOP: 60MIN IS SUFFICIENT FOR MOST APPLICATIONS.  SMALLER AREA SUCH AS UPPER LIP WOULD BE 30-45 MINS.

RAPID ONSET OF ACTION AND DEEP SKIN PENETRATION:  Allows you to concentrate in getting results, not on dealing with uncomfortableness.

LONG DURATION OF EFFECT: The numbing effect lasts for approximately 90 mins.

NON-OILY FORMULA: Wipes clean easily from your skin and provides better penetration than an oil based analgesic.

CLEAR, TRANSCLUCENT GEL: Does  not show white on your skin like other products.  Does not dry out and become flaky like other products.

NO PRESCRIPTION REQUIRED:  Available through your medical technician.

Clinically Proven

TOPICAINE demonstrated a very rapid onset with a long duration of cutaneous anesthesia in a prospective, randomized, double-blinded, controlled study investigating the efficacy of EMLA, LMX-5 and TOPICAINE.

Dermatol. Surg 2001;27:1019-1026

"This was an independent study conducted at the Department of Dermatolgy of New York University.  TOPICAINE showed the highest level of anesthetic efficacy overall."

Medical Information

DESCRIPTION

TOPICAINE® is a hydro-ethanolic, non-oily, translucent microemulsion gel containing lidocaine 5% with skin permeation enhancers and soothing agents, indicated as a topical anesthetic for use on normal intact skin for local analgesia.

COMPOSITION

Each gram of TOPICAINE® contains lidocaine 50 mg in a gel composed of water, ethanol (35% w/w), glycerin, jojoba oil, aloe vera oil, glyceryl monolaurate, benzyl alcohol, carbomer 940, EDTA. TOPICAINE® has a pH of 7.5.

The chemical designation of Lidocaine (syn. Lignocaine) is 2-(diethylamino)-N(2,6-dimethylphenyl), acetamide; MP 68-69 degrees centigrades ; MW 234.33. It has the following structure:

MECHANISM OF ACTION

TOPICAINE® applied to intact skin provides dermal analgesia by the release of lidocaine from the gel into the epidermis and dermis. Lidocaine is a local anesthetic agent of the amide type. Local anesthetics reversibly block the initiation and conduction of nerve impulses by interfering with the flux of sodium ions though the neuronal membrane. The onset, depth and duration of dermal analgesia provided by TOPICAINE® depend primarily on the site of application and duration of application. Adequate dermal analgesia is obtained after 1 hour of application, and the effect persists for approximately 1 hour after removal. Areas such as the upper lip may be numb after 30 minutes of application. Dermal application of TOPICAINE® may cause local blanching followed by local redness or erythema. These effects are mild and transitory.

INDICATION AND USAGE

TOPICAINE® (lidocaine 5%) is indicated for the temporary relief of pain and itching. It is a topical analgesic for use on normal intact skin for local pain relief.

TOPICAINE® is not recommended for use on mucous membranes because of much greater absorption than through intact skin. TOPICAINE® is not recommended for use beyond the external ear. Not for ophtalmic use.

CONTRAINDICATION

TOPICAINE® is contraindicated in patients with sensitivity to the amide type local anesthetics or to any other component of the product.

WARNINGS

For external use only. Avoid contact with the eyes. Do not use over large areas of the body. Do not use for more than 7 days unless directed by a doctor. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Inappropriate use of this product, such as application on mucous membranes,  or on individuals that are allergic to the amide type anesthetics, may result in serious side effects. Consultation with a doctor before using this product is strongly recommended.

PRECAUTIONS

General:

Repeated doses of TOPICAINE® may increase blood levels of lidocaine. Avoid contact with the eye since it may cause severe irritation and loss of protective reflexes. If eye contact occurs, immediately wash out the eye with water or saline. Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations of lidocaine.

Information for patients:

When TOPICAINE® is used the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing or exposure to extreme hot or cold temperatures until complete sensation has returned.

Drug interactions:

TOPICAINE® should be used with caution in patients receiving Class I antiarrythmic agents (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.

Nursing mothers:

Lidocaine is excreted in human milk, therefore, caution should be exercised when TOPICAINE® is administered to a nursing mother since the milk:plasma ratio of lidocaine is 0.4.

Pediatric use:

Consult a doctor. Observe child during application to avoid accidental ingestion. Not for otic or ophtalmic use.

ADVERSE REACTIONS

Localized reactions:

During or immediately after treatment with TOPICAINE® the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. These effects are mild and transient, resolving spontaneously within 1 or 2 hours. Other common effects is paleness (pallor or blanching) when the application time is very prolonged (over 2 hours), and less frequently alterations in temperature sensations, edema, itching and rash.

Allergic Reactions:

Allergic and anaphylactoid reactions associated with lidocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock.