Benzocaine

Benzocaine is a topical local anesthetic that’s applied to the skin, mouth or gums to numb nerve endings. It relieves pain and itching caused by conditions like insect bites, sore throats and toothaches. The U.S. Food and Drug Administration warns against using over-the-counter benzocaine products to relieve teething pain in infants because the anesthetic can cause a rare, sometimes fatal blood condition called methemoglobinemia.

Benzocaine - Cetacaine
Benzocaine Facts
  1. Uses Topical pain relief of variety of conditions, including, canker sores, insect bites, hemorrhoids, poison ivy, ingrown toenails, and irritation of the mouth and gums
  2. Serious Side Effects Methemoglobinemia
  3. Brands and Manufacturers Anbesol (Pfizer), Orajel (Church & Dwight), Cepacol (Reckitt Benckiser), Chloraseptic (Prestige Brands), HurriCaine (Beutlich Pharmaceuticals), Orabase (Colgate-Palmolive), Topex (Sultan Healthcare)

Benzocaine is a topical pain reliever found in many over-the-counter products, including creams, gels, liquids, ointments, pads, sprays, lozenges and swabs. It is also available in some prescription medications.

People use these products for their numbing effects. Orajel, Americaine and Cetacaine are among the many name-brand products that contain the anesthetic.

Oral use of these products has been linked to a rare but serious blood condition called methemoglobinemia (pronounced “met-he-mo-glo-bi-nemia”). This potentially fatal side effect of benzocaine causes the amount of oxygen in the bloodstream to become dangerously low.

As a result, the U.S. Food and Drug Administration issued a safety announcement in May 2018 stating that benzocaine oral drug products should not be used in children 2 and under. The FDA also called for warnings on product labels about the link to methemoglobinemia.

Fact
According to the U.S. Food and Drug Administration, benzocaine products “are not useful” for treating infants’ sore gums because they wash out of the mouth within minutes, and they can be dangerous.

What Is Benzocaine?

Benzocaine is a chemical compound derived from para-aminobenzoic acid and ethanol. It is a white, odorless, crystalline powder. It acts on neuronal membranes and blocks nerve signals in the body. Its numbing effects are temporary.

The chemical formula for benzocaine
Benzocaine is a chemical compound.

People use the anesthetic to relieve pain or discomfort. It is not recommended for long-term use. The gels, creams and other products can treat insect bites, minor cuts and scratches, and exposure to poison ivy, oak or sumac. The medication also provides relief for canker sores, cold sores and fever blisters. It’s also used to treat vaginal and rectal irritation and is sometimes used in sexual enhancement products to desensitize male genitalia.

Products

Benzocaine is the active ingredient in many over-the-counter analgesic products. The gels and creams relieve pain, itching and other irritations. The numbing agent is also the main ingredient in a number of sprays and lozenges that can treat mouth and throat pain.

Some over-the-counter brands include:
  • Anbesol
  • Topex
  • Orajel
  • Anacaine
  • Cetacaine
  • Orabase
  • Medicone
  • Americaine
  • Solarcaine
  • HurriCaine

Health care professionals also use the sprays to numb the lining of the mouth and throat during procedures and to suppress the gag reflex. Such procedures include inserting instruments down the throat to view internal organs, and inserting breathing tubes and feeding tubes. Benzocaine products are not FDA-approved for these uses.

Precautions

The FDA and the Mayo Clinic offer several precautions to take when using products that contain the topical anesthetic.

  • Don’t use benzocaine products if you have ever had methemoglobinemia.
  • Don’t use more than the smallest amount of this medication needed.
  • Don’t apply benzocaine more than four times a day.
  • Don’t get the product in your eyes.
  • Avoid swallowing the gel, liquid or ointment.
  • Don’t apply benzocaine products to open wounds, burns, broken or inflamed skin.
  • Don’t use the product near an open flame or while smoking because benzocaine is flammable.

The medication can be absorbed into the bloodstream through the skin, and an overdose can be fatal. To avoid overdosing, use only the minimum amount needed. A doctor will be able to advise you on the proper dosage. If you suspect an overdose, contact poison control or an emergency room right away.

When to Talk to Your Doctor

In general, you should ask your doctor for guidance before you use the numbing medication. This is especially true if you are taking medicines that contain nitrates, including nitroglycerin. Also discuss benzocaine use with your physician if:

  • You have any blood disease or genetic enzyme deficiency
  • You have heart disease
  • You have lung or breathing problems, including asthma, bronchitis or emphysema

Benzocaine use during pregnancy is generally thought to be safe, but it hasn’t been studied thoroughly. You should talk to your doctor before using the medication if you are pregnant or may become pregnant.

2018 FDA Teething Warning

The FDA issued a safety bulletin on May 23, 2018, regarding over-the-counter benzocaine products used for teething and mouth pain. The bulletin also applied to prescription local anesthetics, including: articaine, bupivacaine, chloroprocaine, , mepivacaine, prilocaine, ropivacaine and tetracaine.

“Any potential benefits of using OTC oral health care drug products containing benzocaine to treat sore gums due to teething do not outweigh the risks of methemoglobinemia … There are safer non-drug alternatives available for teething pain.”

Source: U.S. Food and Drug Administration, May 21, 2018

The agency noted the products can cause methemoglobinemia, “which can be life-threatening and result in death.” According to a 2013 study in the Journal of the American Dental Association, most cases of methemoglobinemia have occurred following a “significant” overdose of the drug. But even small amounts can be dangerous to infants.

The FDA urged manufacturers of over-the-counter oral benzocaine products to add warnings to their label about methemoglobinemia. The agency urged label changes that also directed the products not be used for teething or for any reason in children younger than 2.

Following the FDA announcement, attorneys began preparing benzocaine lawsuits against manufacturers on behalf of infants, children and adults who developed methemoglobinemia after using over-the-counter oral health products that contain the numbing agent.

Alternatives for Teething Pain

The FDA says the risks outweigh any potential benefits of using benzocaine to treat teething pain in children under 2. The agency suggests following the recommendations of the American Academy of Pediatrics instead.

The academy says to gently rub or massage the child’s gums with your finger. You can also give the child a firm, rubber teething ring. The academy says frozen teething rings get too hard and can cause more harm than good.

The academy also recommends against using teething tablets that contain the plant poison belladonna.

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Nurse Amy Keller
Written By Amy Keller, RN Registered Nurse

Amy Keller is a registered nurse and award-winning journalist with 22 years of experience writing about politics, business, health and other topics. At Drugwatch, she draws on her clinical experience and investigative reporting skills to write about consumers’ health concerns such as the safety of online pharmacies. She also provides informed analysis on complex health issues. Some of her qualifications include:

  • Recipient of USF’s Nurse Alumni Nightingale award for excellence in nursing
  • Guest Faculty Speaker, “Moving Forward with Patient- and Family-Centered Care Intensive Training Seminar”
  • Member of Sigma Theta Tau International Honor Society of Nursing
Edited By

16 Cited Research Articles

  1. American Academy of Pediatrics. (n.d.) Teething: 4 to 7 Months. Retrieved from  https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx
  2. CBS News. (2018, May 23). FDA warns benzocaine gel teething products are unsafe, wants them off the market. Retrieved from  https://www.cbsnews.com/news/fda-warning-benzocaine-gel-orajel-teething-products/
  3. Cigna. (n.d.) benzocaine topical. Retrieved from  https://www.cigna.com/individuals-families/health-wellness/hw/medications/benzocaine-topical-d00813a1
  4. Douglas, W.W. and Fairbanks, V.F. (1977, May). Methemoglobinemia Induced by a Topical Anesthetic Spray (Cetacaine). Retrieved from  https://journal.chestnet.org/article/S0012-3692%2816%2940543-X/abstract
  5. Garvin, J. (2018, May 24). FDA warns consumers against using benzocaine products. Retrieved from  https://www.ada.org/en/publications/ada-news/2018-archive/may/fda-warns-consumers-against-using-benzocaine-products
  6. Government of Canada. (2012, April 5). Benzocaine health products: new risk statements to be added to product labels. Retrieved from  http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2012/13671a-eng.php
  7. Hegedus, F. and Herb, K. (2005, Winter). Benzocaine-induced Methemoglobinemia. Retrieved from  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1586795/
  8. Hersh, E. (2013, May). An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches: Efficacy, tolerability and compliance with label dose administration directions. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3844156/
  9. Mayo Clinic. (2018, October 1). Benzocaine (Topical Application Route): Precautions. Retrieved from https://www.mayoclinic.org/drugs-supplements/benzocaine-topical-application-route/precautions/drg-20072913
  10. Mayo Clinic. (2018, October 1). Benzocaine (Topical Application Route): Proper Use. Retrieved from https://www.mayoclinic.org/drugs-supplements/benzocaine-topical-application-route/proper-use/drg-20072913
  11. U.S. Food and Drug Administration. (2018, June 25). Safety Information on Benzocaine-Containing Products. Retrieved from  https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm273111.htm
  12. U.S. Food and Drug Administration. (2018, May 21). FDA Letter Regarding Benzocaine. Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM608534.pdf
  13. U.S. Food and Drug Administration. (2018, May 23). Do Teething Babies Need Medicine on Their Gums? No. Retrieved from  https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm385817.htm
  14. U.S. Food and Drug Administration. (2018, May 23). FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. Retrieved from  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  15. U.S. Food and Drug Administration. (2018, May 23). Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. Retrieved from  https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm
  16. U.S. National Library of Medicine. (n.d.). Benzocaine. Retrieved from  https://pubchem.ncbi.nlm.nih.gov/compound/benzocaine#section=Top
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