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Apr 19, 2011

Warning: products containing benzocaine, an ingredient used to reduce pain in the mouth and gums.

FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth.

"On April 7, 2011, the U.S. Food and Drug Administration (FDA) warned the public about the use of over-the-counter (OTC) products containing benzocaine, an ingredient used to reduce pain in the mouth and gums. Benzocaine use may cause a rare, but serious condition where the amount of oxygen that can be carried through the blood stream is greatly reduced. This condition is called methemoglobinemia. FDA is particularly concerned about the use of OTC benzocaine products in children for relief of pain from teething because of the serious outcomes, including death, that may be associated with methemoglobinemia, as well as the difficulty parents or consumers may have in recognizing the signs and symptoms of methemoglobinemia when using these products at home. Furthermore, symptoms of methemoglobinemia may not always be evident or attributed to the condition.
Parents and caregivers should not use OTC benzocaine products on children under two years of age, except under the advice and supervision of a healthcare professional. If benzocaine products are used, it should be used sparingly and only when needed, but not more than four times a day.
Below is some additional information about benzocaine, methemoglobinemia, and steps consumers can take if they have or recognize an adverse reaction after using an OTC product containing benzocaine."

List of OTC Benzocaine Products

Americaine
Dent’s Maxi-Strength Toothache
Orajel Medicated Toothache
Americaine Hemorrhoidal
Dermoplast Antibacterial
Orajel Mouth Sore
Anbesol
Dermoplast Painrelieving
Orajel Multi-Action Cold Sore
Anbesol Baby
Detane
Orajel PM
Anbesol Cold Sore Therapy
Dry Socket Remedy
Orajel Ultra Mouth Sore
Anbesol Jr.
Exactacain
Oticaine
Anbesol Maximum Strength
Foille
Otocain
Baby Orajel
Freez Eez
Outgro
Banadyne
HDA Toothache
Red Cross Canker Sore
Benzocaine Burn Spray
Hurricaine
Rid-A-Pain Dental Drops
Benzodent
Ivy-Rid
Skeeter Stik
Boil Ease Maximum Strength
Kanka Soft Brush
Sting-Kill
Cepacol Sore Throat
Lanacane
Tanac
Cetacaine
Lanacane Maximum Strength
Thorets
Chiggerex
Mycinettes
Topicale Xtra
Chiggertox
Navogan
Trocaine
Comfort Caine
Orabase with Benzocaine
Walgreens Oral Anesthetic Paste
Dentapaine
Orajel Denture Plus
Walgreens Zilactin-B
Dent’s Extra Strength Toothache
Orajel Maximum Strength
Zilactin Toothache and Gum Pain


Here are some some: Questions & Answers: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth

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