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

Starting date:
April 5, 2012
Posting date:
April 5, 2012
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety, Labelling and Packaging
Audience:
General Public
Identification number:
RA-110005586

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.

Affected benzocaine products currently approved in Canada

Affected benzocaine products
Product Name Importer/Manufacturer DIN/NPN/ENTable 1 footnote 1

Table 1 footnotes

Table 1 footnote 1

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.

Return to table 1 footnote 1 referrer

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 Ltée 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

 

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