Antipyrine Benzocaine Ear Drop available or banned?

Antipyrine Benzocaine Ear Drop available or banned?

It is a combination of products used to clean the ear, and relieve pain, swelling, congestion, or any kind of discomfort caused by the middle ear infection. This can also be helped to remove wax. It may be used to treat ear infections when included with other antibiotics. Antipyrine is an analgesic to decrease the pain and Benzocaine is an anesthetic useful to numb the pain. 

Mostly available by the brand name Auralgan and Aurodex, Antipyirine’s marketing was stopped by the FDA in 2015 as it wasn’t proven to be safe or effective for ears. It is now available as a generic drug, but cannot be provided by any pharmacist without a description.

How to use Antipyrine Benzocaine Ear Drop?

Antipyrine Benzocaine ear drop comes as a liquid solution. Lie down keeping the affected ear upwards, holding the dropper directly over the ear, and placing several drops directly into the ear canal as prescribed by your consulting doctor. Holding the earlobe upside and back will help spread the drops well inside. Do not touch the tip of the dropper with your fingers, any surface, or even your ear, keep a distance while using it. You can use moist cotton with the same drop, to cover the ear. Repeat the same steps for another ear to clean the wax (or as per consultation with your doctor).


The dose of Antipyrine Benzocaine ear drop will differ for different patients or as directed by your doctor. Mostly the amount of the medicine suggested is according to the level of infection and problem or the strength of the medication.

  • For adults, the drop is suggested every 2-3 hours, if the pain and infection is more
  • For children, it is recommended only 2 or 3 times a day
  • For adults, if it is being used for removing ear wax or softening, it is suggested 3 times a day
  • For children, it is recommended only for 1 time in a whole day.

Other Uses

For more information related to other kinds of uses, kindly consult your doctor.

Side effects of Antipyrine Benzocaine Ear Drop

Some of the common side effects can be:

  • Burning inside the ear
  • Stinging
  • Redness inside or around the ear
  • Any other kind of pain inside the ear
  • Any other kind of pain around the ear
  • Problem in hearing
  • The stickiness of the ear wax

A very serious problem has been rarely noticed after using these ear drops, still, try to contact your doctor immediately if any of the following problems occur- Loss of breath, any kind of skin disorder nearby the ear or on the face including redness, bluish, gray skin, fast heartbeat, dizziness, headache. 

Note: Above mentioned may not be a complete list of side effects or after-effects of Antipyrine Benzocaine ear drop, so kindly consult your doctor in case of any other effects after using the ear drop.

Precautions to follow

Before using the Antipyrine Benzocaine Ear Drop

  • Your pharmacist or doctor should know if you are allergic to Antipyrine, or other eardrop, antibiotics, or any other drugs.
  • Your pharmacist or doctor should know about your other medications especially other ear medications, vitamins, nutritional supplements, or if you are planning to take any herbal product.
  • Your doctor should know if you are pregnant or planning to become, or are breastfeeding. Let your doctor know in case you take it at the time of any such conditions.
  • You should not breastfeed while taking this medication, as while doing it, it can pass through and affect the nursing baby. It has proven not to be used for children under 2 years.

Note: This medication should not be shared with anyone else, as it may vary according to your conditions and others. Also not be used, once the doctor advises or if your ear is perfectly fine.

Drug Interactions

There are no proven drug interactions for this ear drop, Still, your doctor or pharmacist must be aware of any other kind of medication if you are taking it. So do not change or start a new medication at the time of using these ear drops.

The above information may not be complete, so kindly consult your doctor before using any other kind of medicine.

Dietary measures to follow

As such there are no specific dietary instructions to be followed with Antipyrine Benzocaine Ear Drop unless your doctor prescribes any. Below are some of the cases that in case need to be consulted with your doctor on priority.


Let your consulting doctor know if you are allergic to any ear drops or any other kind of medication. Let him/her be aware of your allergies(if any) to any eatables, like peanuts, any fruit, lemon, any specific smell or taste, dyes, preservatives, or animals. Do read the package ingredients carefully before use. 


Infants may be sensitive to the effects of the Benzocaine in Antipyrine Benzocaine Ear drop, further increasing the side effects. You need to consult a pediatrician before using any kind of ear drop. However, this is not proven with any side effects to older children as adults.


This eardrop or similar medications are rarely been studied as per elderly people’s health. So there is no proven statement about any kind of different side effects as compared to younger adults. Still consulting your doctor before using.


Keep the container tightly closed in the package it came in and especially out of the reach of children. Store it away from excess heat and moisture and also at room temperature. Used or not needed medicines should be safely disposed of off to ensure that it does not come into contact with or consumption by pets, children, or maybe anyone else. The best way to choose to dispose of is through a medicine take-back program. Learn more about it through your pharmacist or contact your local recycling department. It is definitely important to keep the containers out of reach of children to avoid misuse of it. Mostly the containers are not child-resistant, so they can open or try it easily.

The unapproved prescription ear drops incorporate lively substances including benzocaine and hydrocortisone and the feature is now no longer being evaluated via way of means of the FDA for protection, effectiveness, and quality. The labels on those merchandise now no longer expose that they lack FDA approval, and fitness care experts might not be aware of their unapproved status. 

Store in the refrigerator but do not freeze it, if not keep it away from sunlight or direct heat or in the foil pouch at room temperature for about a maximum of 28 days. Do not use it more than that.

Other Information to Know

Auralgan (benzocaine and antipyrine) otic drops are now no longer in manufacturing.

 The FDA introduced its goal to take enforcement motion towards businesses that manufacture and/or distribute sure unapproved prescription ear drop merchandise (referred to as otic merchandise) categorized to alleviate earache, infection, and inflammation. 

Unapproved prescription otic drug merchandise is regularly given to younger kids laid low with ear infections and different situations that reason earache and swelling. Patients taking unapproved tablets can be in extra danger due to the fact there may be no confirmed protection or effectiveness information. This merchandise can be infected or synthetic incorrectly, which could bring about sufferers receiving the incorrect dose, even if administered in step with the categorized instructions for use.

Unprescribed and unapproved ear drops and similar medications containing the following ingredients are covered by this action: 

  • Benzocaine
  • Antipyrine and Benzocaine
  • Zin acetate, Benzocaine, and Antipyrine
  • Chloroxylenol, Benzocaine, and hydrocortisone
  • Pramoxine and Chloroxylenol
  • Chloroxylenol, Hydrocortisone, and Pramoxine


We have tried our best to give every possible information about Antipyrine Benzocaine Eardrop which we mean to be correct, comprehensive, and up to date. However, this article should not be used as instruction from a healthcare professional.

Patients should consult their doctor before consuming Prednisone, and avoid overdose or improper consumption. In case of any side effects be it short-term or long-term, kindly immediately call up your doctor for changing the dosage or medication of the treatments.

In the US- You can call up your medical consultant or a doctor for advice about side effects, you may also report FDA at 1-800 FDA-1088

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