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

OTTAWA, April 5, 2012 /CNW/ - 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 Liquid	Paladin Labs Inc.	NPN 02237869
Anbesol® Gel	Paladin Labs Inc.	NPN 02238100
Auralgan Solution	Paladin Labs Inc.	DIN 02332477
Baby Orajel	Church & Dwight Canada Corporation	NPN 00075876
Baby Orajel Liquid	Church & Dwight Canada Corporation	NPN 02229697
Baby Orajel Nighttime Formula	Church & Dwight Canada Corporation	NPN 02256401
Baby Orajel Teething Swabs	Church & Dwight Canada Corporation	NPN 02247556
Balsaris; Balzarol	Le Groupe M. Vachon Inc.	NPN 00654825
Baume Sensations	Eau Zone Huiles & Fragrances Ltee	EN 128267
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 Relief Sore Throat Spray	Reckitt Benckiser (Canada) Inc.	NPN 80015639
Chloraseptic Sore Throat Relief Strips	Prestige Brands Inc.	NPN 02252457
Colt	Produits Mameca	NPN 80008865
Comfortcaine Topical Anesthetic	Harry J. Bosworth Company	EN 160256
Cora Caine	Coralite Dental Products	DIN 00070254
Denti-Care Denti-Freeze Topical Anesthetic Gel	A.R. Medicom Inc.	DIN 02318148
Denti-Care Topical Anesthetic Gel	A.R. Medicom Inc.	DIN 02239705
Dermacaine-R	Innovatech Inc	DIN 02344971
Desensitizing Pleasure Balm	Kamsute Inc. Dba The Kama Sutra Company	EN 167539
Dukal Sting Relief Pad	Dukal Corporation	EN 170542
Equate Oral Analgesic Maximum Strength Gel	Lornamead Inc.	EN 151460
Extra Strength Vagisil	Combe Incorporated	NPN 02243776
EZ Freeze Topical Anaesthetic Gel	Maxill Inc.	DIN 02241350
First Aid Spray	Canadian Custom Packaging/The Color Group Division	NPN 00654973
Freez-Eez, Bubblegum/ Mint/ Strawberry/ Cherry/ Grape/ Raspberry	Germiphene Corporation	NPN 02245342
Hemovirtu's Hemorrhoidal Ointment	Virtu's Industria E Commércio LTDA	DIN 02240906
Henry Schein Topical Anesthetic Gel	ABJ Custom Packaging	DIN 02237329
Hurricaine® Topical Anesthetic Gel	Beutlich L.P.	NPN 00481122
Hurricaine® Topical Anesthetic Liquid	Beutlich L.P.	NPN 00481130
Hurricaine® Topical Anesthetic Spray	Beutlich L.P.	NPN 02261561
Hurricane Snap-N-Go Swabs	Lornamead Inc.	EN 157623
Kank-A Liq	Blistex Corporation	DIN 02024659
Lanacane Anti-Bacterial First Aid Spray	Reckitt Benckiser (Canada) Inc.	DIN 02253364
Lanacane Crème Medication	Reckitt Benckiser (Canada) Inc.	NPN 00534463
Lanacane Extra Strength	Reckitt Benckiser (Canada) Inc.	NPN 02244512
Life Brand Oral Anesthetic Maximum Strength Liquid	Lornamead Inc.	EN 154232
Life Brand Severe Toothache Pain Relief	Lornamead Inc.	EN 155731
Little Teether's Oral Pain Relief Gel	Prestige Brands Inc.	NPN 02270099
Lollicaine	Centrix Incorporated	NPN 80016262
New Choice Vagi-Cure Anti-Itch Cream	SCI International	EN 171846
New Choice Vagi-Cure Anti-Itch Cream	SCI International	EN 171847
Numbing Gel	CMI Cosmetic Manufacturers Inc.	DIN 02230545
Numbing Spray	CMI Cosmetic Manufacturers Inc.	DIN 02230546
One Touch Topical Anesthetic Gel	ABJ Custom Packaging	DIN 02230958
Oragard-B Analgesic Oral Paste 20%	Colgate Oral Pharmaceuticals Inc.	NPN 02027380
Orajel For Cold Sores	Church & Dwight Canada Corp.	DIN 02374358
Orajel For Cold Sores Relief & Concealer	Church & Dwight Canada Corp.	DIN 02374323
Orajel Maximum Strength	Church & Dwight Canada Corporation	NPN 01985396
Orajel Maximum Strength Liquid 20%	Church & Dwight Canada Corporation	NPN 01985620
Orajel Medicated Mouth Sore Swabs	Church & Dwight Canada Corporation	NPN 02247149
Orajel Medicated Toothache Swabs	Church & Dwight Canada Corporation	NPN 02247151
Orajel Mouth Sore Medicine	Church & Dwight Canada Corporation	NPN 02241509
Orajel PM	Church & Dwight Canada Corporation	NPN 02230520
Orajel Regular Strength	Church & Dwight Canada Corporation	NPN 02256363
Orajel Ultra Canker Sore Medicine	Church & Dwight Canada Corporation	NPN 02261316
Oraljel Denture Plus	Church & Dwight Canada Corporation	NPN 02261308
Osmopak Plus	Rougier Pharma, Division Of Teva Canada Limited	NPN 00385387
Outgro	Medtech Products, Inc.	NPN 02231569
Oxipor Lotion	Medtech Products Inc.	DIN 02230134
PDI Sting Relief	Professional Disposables International Ltd.	NPN 02237901
Play Longer	Durex Canada (Division Of SS Canada Inc.)	NPN 02261480
PMS-Oral Pain Gel 10%	Pharmascience Inc.	NPN 02124963
Projel-20	Novocol Pharmaceutical Of Canada, Inc.	EN 505375
Rectogel	Laboratoire Riva Inc.	EN 159721
Rectogel HC	Laboratoire Riva Inc.	DIN 00662461
Shunga Erotic Art	Eau Zone Huiles & Fragrances Ltee	EN 151856
Solarcaine First Aid Spray	Schering-Plough Canada Inc.	DIN 01918893
Sorbet Topical Anaesthetic Gel	Mycone Dental Supply Co. Inc. (Trading As Keystone Industries)	NPN 80024117
Sting Kure	Produits Mameca	NPN 80021323
Supra Gelcaine Topical Gel Anesthetic	Hansamed Limited	DIN 02245863
Tanac Liquid	Insight Pharmaceuticals Corporation	DIN 02247644
Thermo-Gel	Laboratories Confab Inc.	NPN 00741523
Topex Topical Anesthetic Gel	Sultan Healthcare	NPN 00638358
Topex Topical Anesthetic Metered Spray	Sultan Healthcare	NPN 02244285
Topicale Gel Pump Pina Colada	Medical Products Labs	DIN 01945726
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 Cool Mint	Germiphene Corporation	DIN 01930699
Zap Topical Anesthetic Spray	Germiphene Corporation	DIN 02240984
Zap Topical Anesthetic Spray Aerosol (Strawberry Ice And Cool Mint)	Germiphene Corporation	DIN 02253127
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

 

For further information:

Media Enquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866 225-0709

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