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
Également disponible en français
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