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Last updated on April 24, 2014 at 16:36 EDT

Information Update – Benzocaine health products: new risk statements to be added to product labels

April 5, 2012

OTTAWA, April 5, 2012 /PRNewswire/ – Health Canada is informing Canadians that
it has requested companies to add new risk statements to the packaging
and labelling of licensed benzocaine products. In April 2011, Health
Canada reminded Canadians of certain health risks associated with benzocaine
products,
including a very rare but serious blood condition known as
methemoglobinemia that can affect sensitive individuals. The new
statements are intended to further raise awareness of these risks and
promote the safe use of benzocaine products.

As with any health product, Canadians are reminded to carefully read and
follow the instructions for product use. If you or your child
experience weakness, confusion, headache, difficulty breathing and/or
pale, gray or blue coloured skin, stop use of the benzocaine product
and seek medical attention as these may be symptoms of
methemoglobinemia. Speak to a healthcare practitioner if you have
questions or concerns about a benzocaine product, particularly before
use in a child under two years of age.

Products that contain the medicinal ingredient “benzocaine” are used in
children and adults to relieve pain due to a variety of conditions,
including: teething, sore throats, toothache,canker sores, mouth or gum
irritation, itching, hemorrhoids, and as a first-aid treatment for
burns and insect bites. Benzocaine is also used as a desensitizer in
sexual enhancement products.

Most benzocaine products are available over-the-counter in a range of
formulations including gels, sprays, swabs, liquids, lotions, lozenges
, while a small number require a prescription from a healthcare
practitioner. Benzocaine products are also used in healthcare settings
during surgical, dental and other medical procedures to numb the mouth
and throat.

The label changes apply to all benzocaine products except lozenges (as
the risk of methemoglobinemia has not been associated with lozenges).
See below for a list of affected benzocaine products.

New risk statements:

The new risk statements provide added instructions with respect to the
risk of methemoglobinemia and for safe product use, including the
importance of using the smallest amount possible. In addition, they
provide guidance on recognizing the signs and symptoms of
methemoglobinemia, and child safety.

        --  Stop use and consult a healthcare practitioner if the following
            symptoms appear: weakness, confusion, headache, difficulty
            breathing and/or pale, gray or blue coloured skin as these may
            be signs of methemoglobinemia, a rare disorder, which may
            appear up to 2 hours after use.
        --  Do not use in large quantities or over large areas of the body
            (OR, Use smallest amount possible to achieve desired result).
        --  Do not use if allergic to benzocaine or any other ingredient in
            the product.
        --  Keep out of reach of children.
        --  Use with caution in children. [For all products except those
            intended for use in children under two years old]
        --  Consult a healthcare practitioner prior to use for children
            less than 2 years of age. [For products intended for use in
            children under two years old, such as oral teething gels or
            body lotions]

Some products may already contain information to this effect. Health
Canada is requesting companies add the above statements to product
packages and labels if they do not already appear, to ensure
consistency in the labelled information and to help consumers use these
products more safely. Exact wording for some statements may vary
depending on product type.

Companies will be implementing the label changes over the next six
months. During this time, products that may not have the updated
precautionary statements can remain available on store shelves.

How to report side effects to health products to Health Canada

        --  Call toll-free at 1-866-234-2345
        --  Visit MedEffect Canada's web page on
            Adverse Reaction Reporting
            for information on how to report online, by mail or by fax.

Affected benzocaine products currently approved in Canada

     _____________________________________________________________________
    |Product Name               |Importer/Manufacturer       |DIN/NPN/EN**|
    |___________________________|____________________________|____________|
    |Anbesol® Baby Gel          |Paladin Labs Inc.           |NPN 02049449|
    |___________________________|____________________________|____________|
    |Anbesol® Extra Strength Gel|Paladin Labs Inc.           |NPN 02237870|
    |___________________________|____________________________|____________|
    |Anbesol® Extra Strength    |Paladin Labs Inc.           |NPN 02237869|
    |Liquid                     |                            |            |
    |___________________________|____________________________|____________|
    |Anbesol® Gel               |Paladin Labs Inc.           |NPN 02238100|
    |___________________________|____________________________|____________|
    |Auralgan Solution          |Paladin Labs Inc.           |DIN 02332477|
    |___________________________|____________________________|____________|
    |Baby Orajel                |Church & Dwight Canada      |NPN 00075876|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Baby Orajel Liquid         |Church & Dwight Canada      |NPN 02229697|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Baby Orajel Nighttime      |Church & Dwight Canada      |NPN 02256401|
    |Formula                    |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Baby Orajel Teething Swabs |Church & Dwight Canada      |NPN 02247556|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Balsaris; Balzarol         |Le Groupe M. Vachon Inc.    |NPN 00654825|
    |___________________________|____________________________|____________|
    |Baume Sensations           |Eau Zone Huiles & Fragrances|EN 128267   |
    |                           |Ltee                        |            |
    |___________________________|____________________________|____________|
    |Burn O Sol Spray           |Protector Canada Inc.       |DIN 01936220|
    |___________________________|____________________________|____________|
    |Cetacaine Liquid           |Cetylite Industries Inc.    |DIN 02028867|
    |___________________________|____________________________|____________|
    |Cetacaine Spray            |Cetylite Industries Inc.    |DIN 02028840|
    |___________________________|____________________________|____________|
    |Cherry Cepacol Soothing    |Reckitt Benckiser (Canada)  |NPN 80015639|
    |Relief Sore Throat Spray   |Inc.                        |            |
    |___________________________|____________________________|____________|
    |Chloraseptic Sore Throat   |Prestige Brands Inc.        |NPN 02252457|
    |Relief Strips              |                            |            |
    |___________________________|____________________________|____________|
    |Colt                       |Produits Mameca             |NPN 80008865|
    |___________________________|____________________________|____________|
    |Comfortcaine Topical       |Harry J. Bosworth Company   |EN 160256   |
    |Anesthetic                 |                            |            |
    |___________________________|____________________________|____________|
    |Cora Caine                 |Coralite Dental Products    |DIN 00070254|
    |___________________________|____________________________|____________|
    |Denti-Care Denti-Freeze    |A.R. Medicom Inc.           |DIN 02318148|
    |Topical Anesthetic Gel     |                            |            |
    |___________________________|____________________________|____________|
    |Denti-Care Topical         |A.R. Medicom Inc.           |DIN 02239705|
    |Anesthetic Gel             |                            |            |
    |___________________________|____________________________|____________|
    |Dermacaine-R               |Innovatech Inc              |DIN 02344971|
    |___________________________|____________________________|____________|
    |Desensitizing Pleasure Balm|Kamsute Inc. Dba The Kama   |EN 167539   |
    |                           |Sutra Company               |            |
    |___________________________|____________________________|____________|
    |Dukal Sting Relief Pad     |Dukal Corporation           |EN 170542   |
    |___________________________|____________________________|____________|
    |Equate Oral Analgesic      |Lornamead Inc.              |EN 151460   |
    |Maximum Strength Gel       |                            |            |
    |___________________________|____________________________|____________|
    |Extra Strength Vagisil     |Combe Incorporated          |NPN 02243776|
    |___________________________|____________________________|____________|
    |EZ Freeze Topical          |Maxill Inc.                 |DIN 02241350|
    |Anaesthetic Gel            |                            |            |
    |___________________________|____________________________|____________|
    |First Aid Spray            |Canadian Custom             |NPN 00654973|
    |                           |Packaging/The               |            |
    |                           |Color Group Division        |            |
    |___________________________|____________________________|____________|
    |Freez-Eez, Bubblegum/ Mint/|Germiphene Corporation      |NPN 02245342|
    |Strawberry/ Cherry/ Grape/ |                            |            |
    |Raspberry                  |                            |            |
    |___________________________|____________________________|____________|
    |Hemovirtu's Hemorrhoidal   |Virtu's Industria E         |DIN 02240906|
    |Ointment                   |Commércio LTDA              |            |
    |___________________________|____________________________|____________|
    |Henry Schein Topical       |ABJ Custom Packaging        |DIN 02237329|
    |Anesthetic Gel             |                            |            |
    |___________________________|____________________________|____________|
    |Hurricaine® Topical        |Beutlich L.P.               |NPN 00481122|
    |Anesthetic Gel             |                            |            |
    |___________________________|____________________________|____________|
    |Hurricaine® Topical        |Beutlich L.P.               |NPN 00481130|
    |Anesthetic Liquid          |                            |            |
    |___________________________|____________________________|____________|
    |Hurricaine® Topical        |Beutlich L.P.               |NPN 02261561|
    |Anesthetic Spray           |                            |            |
    |___________________________|____________________________|____________|
    |Hurricane Snap-N-Go Swabs  |Lornamead Inc.              |EN 157623   |
    |___________________________|____________________________|____________|
    |Kank-A Liq                 |Blistex Corporation         |DIN 02024659|
    |___________________________|____________________________|____________|
    |Lanacane Anti-Bacterial    |Reckitt Benckiser (Canada)  |DIN 02253364|
    |First Aid Spray            |Inc.                        |            |
    |___________________________|____________________________|____________|
    |Lanacane Crème Medication  |Reckitt Benckiser (Canada)  |NPN 00534463|
    |                           |Inc.                        |            |
    |___________________________|____________________________|____________|
    |Lanacane Extra Strength    |Reckitt Benckiser (Canada)  |NPN 02244512|
    |                           |Inc.                        |            |
    |___________________________|____________________________|____________|
    |Life Brand Oral Anesthetic |Lornamead Inc.              |EN 154232   |
    |Maximum Strength Liquid    |                            |            |
    |___________________________|____________________________|____________|
    |Life Brand Severe Toothache|Lornamead Inc.              |EN 155731   |
    |Pain Relief                |                            |            |
    |___________________________|____________________________|____________|
    |Little Teether's Oral Pain |Prestige Brands Inc.        |NPN 02270099|
    |Relief Gel                 |                            |            |
    |___________________________|____________________________|____________|
    |Lollicaine                 |Centrix Incorporated        |NPN 80016262|
    |___________________________|____________________________|____________|
    |New Choice Vagi-Cure       |SCI International           |EN 171846   |
    |Anti-Itch Cream            |                            |            |
    |___________________________|____________________________|____________|
    |New Choice Vagi-Cure       |SCI International           |EN 171847   |
    |Anti-Itch Cream            |                            |            |
    |___________________________|____________________________|____________|
    |Numbing Gel                |CMI Cosmetic Manufacturers  |DIN 02230545|
    |                           |Inc.                        |            |
    |___________________________|____________________________|____________|
    |Numbing Spray              |CMI Cosmetic Manufacturers  |DIN 02230546|
    |                           |Inc.                        |            |
    |___________________________|____________________________|____________|
    |One Touch Topical          |ABJ Custom Packaging        |DIN 02230958|
    |Anesthetic Gel             |                            |            |
    |___________________________|____________________________|____________|
    |Oragard-B Analgesic Oral   |Colgate Oral Pharmaceuticals|NPN 02027380|
    |Paste 20%                  |Inc.                        |            |
    |___________________________|____________________________|____________|
    |Orajel For Cold Sores      |Church & Dwight Canada Corp.|DIN 02374358|
    |___________________________|____________________________|____________|
    |Orajel For Cold Sores      |Church & Dwight Canada Corp.|DIN 02374323|
    |Relief & Concealer         |                            |            |
    |___________________________|____________________________|____________|
    |Orajel Maximum Strength    |Church & Dwight Canada      |NPN 01985396|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Orajel Maximum Strength    |Church & Dwight Canada      |NPN 01985620|
    |Liquid 20%                 |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Orajel Medicated Mouth Sore|Church & Dwight Canada      |NPN 02247149|
    |Swabs                      |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Orajel Medicated Toothache |Church & Dwight Canada      |NPN 02247151|
    |Swabs                      |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Orajel Mouth Sore Medicine |Church & Dwight Canada      |NPN 02241509|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Orajel PM                  |Church & Dwight Canada      |NPN 02230520|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Orajel Regular Strength    |Church & Dwight Canada      |NPN 02256363|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Orajel Ultra Canker Sore   |Church & Dwight Canada      |NPN 02261316|
    |Medicine                   |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Oraljel Denture Plus       |Church & Dwight Canada      |NPN 02261308|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Osmopak Plus               |Rougier Pharma, Division Of |NPN 00385387|
    |                           |Teva                        |            |
    |                           |Canada Limited              |            |
    |___________________________|____________________________|____________|
    |Outgro                     |Medtech Products, Inc.      |NPN 02231569|
    |___________________________|____________________________|____________|
    |Oxipor Lotion              |Medtech Products Inc.       |DIN 02230134|
    |___________________________|____________________________|____________|
    |PDI Sting Relief           |Professional Disposables    |NPN 02237901|
    |                           |International Ltd.          |            |
    |___________________________|____________________________|____________|
    |Play Longer                |Durex Canada (Division Of SS|NPN 02261480|
    |                           |Canada Inc.)                |            |
    |___________________________|____________________________|____________|
    |PMS-Oral Pain Gel 10%      |Pharmascience Inc.          |NPN 02124963|
    |___________________________|____________________________|____________|
    |Projel-20                  |Novocol Pharmaceutical Of   |EN 505375   |
    |                           |Canada, Inc.                |            |
    |___________________________|____________________________|____________|
    |Rectogel                   |Laboratoire Riva Inc.       |EN 159721   |
    |___________________________|____________________________|____________|
    |Rectogel HC                |Laboratoire Riva Inc.       |DIN 00662461|
    |___________________________|____________________________|____________|
    |Shunga Erotic Art          |Eau Zone Huiles & Fragrances|EN 151856   |
    |                           |Ltee                        |            |
    |___________________________|____________________________|____________|
    |Solarcaine First Aid Spray |Schering-Plough Canada Inc. |DIN 01918893|
    |___________________________|____________________________|____________|
    |Sorbet Topical Anaesthetic |Mycone Dental Supply Co.    |NPN 80024117|
    |Gel                        |Inc.                        |            |
    |                           |(Trading As Keystone        |            |
    |                           |Industries)                 |            |
    |___________________________|____________________________|____________|
    |Sting Kure                 |Produits Mameca             |NPN 80021323|
    |___________________________|____________________________|____________|
    |Supra Gelcaine Topical Gel |Hansamed Limited            |DIN 02245863|
    |Anesthetic                 |                            |            |
    |___________________________|____________________________|____________|
    |Tanac Liquid               |Insight Pharmaceuticals     |DIN 02247644|
    |                           |Corporation                 |            |
    |___________________________|____________________________|____________|
    |Thermo-Gel                 |Laboratories Confab Inc.    |NPN 00741523|
    |___________________________|____________________________|____________|
    |Topex Topical Anesthetic   |Sultan Healthcare           |NPN 00638358|
    |Gel                        |                            |            |
    |___________________________|____________________________|____________|
    |Topex Topical Anesthetic   |Sultan Healthcare           |NPN 02244285|
    |Metered Spray              |                            |            |
    |___________________________|____________________________|____________|
    |Topicale Gel Pump Pina     |Medical Products Labs       |DIN 01945726|
    |Colada                     |                            |            |
    |___________________________|____________________________|____________|
    |True Test                  |Mekos Laboratories Aps      |DIN 02271885|
    |___________________________|____________________________|____________|
    |Ultracare Gel 20%          |Ultradent Products Inc.     |NPN 00791474|
    |___________________________|____________________________|____________|
    |Vagisil Cream Medication   |Combe Incorporated          |NPN 00534471|
    |___________________________|____________________________|____________|
    |Zap Liquid                 |Germiphene Corporation      |DIN 00443786|
    |___________________________|____________________________|____________|
    |Zap Topical Anesthetic Gel |Germiphene Corporation      |DIN 01930699|
    |Cool Mint                  |                            |            |
    |___________________________|____________________________|____________|
    |Zap Topical Anesthetic     |Germiphene Corporation      |DIN 02240984|
    |Spray                      |                            |            |
    |___________________________|____________________________|____________|
    |Zap Topical Anesthetic     |Germiphene Corporation      |DIN 02253127|
    |Spray Aerosol (Strawberry  |                            |            |
    |Ice And Cool Mint)         |                            |            |
    |___________________________|____________________________|____________|
    |Zilactin-B                 |Blairex Laboratories Inc.   |NPN 02230253|
    |___________________________|____________________________|____________|

** Affected benzocaine health products that have been authorized for
sale by Health Canada will have an eight-digit Drug Identification
Number (DIN), or a Natural Product Number (NPN) on the label. Some
benzocaine natural health products may have an Exemption Number (EN),
which indicates that the product is legally available for sale while
Health Canada is reviewing the application for licensing.

Related Health Canada Web content:

        --  Information Update (April 18, 2011):
            Health Canada reminds Canadians of health risks associated with topical
             benzocaine products
        --  Advisory (November 24, 2006):
            Health Canada advises Canadians of health risks involved with using
             benzocaine
        --  Notice to Hospitals (November 23, 2006):
            Benzocaine Sprays with Methemoglobinemia

 

SOURCE Health Canada


Source: PR Newswire