Each mL contains:

Antipyrine  ............................................ 54.0 mg

Benzocaine ........................................... 14.0 mg

Glycerin dehydrated q.s. to ..................... 1.0 mL

(contains not more than 0.6% moisture)
 (also contains oxyquinoline sulfate)

TOPICAL DECONGESTANT AND ANALGESIC

Auralgan is an otic solution containing antipyrine, benzocaine, and dehydrated glycerin. The solution congeals at 0° C (32° F), but returns to normal consistency, unchanged, at room temperature.

Last updated on RxList: 12/8/2004

ACUTE OTITIS MEDIA OF VARIOUS ETIOLOGIES

prompt relief of pain and reduction of inflammation in the congestive and serous stages

adjuvant therapy during systemic antibiotic administration for resolution of the infection

Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider, and more horizontal than in adults.

REMOVAL OF CERUMEN

facilitates the removal of excessive or impacted cerumen

ACUTE OTITIS MEDIA

Instill Auralgan permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Auralgan and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

REMOVAL OF CERUMEN

Before:  Instill Auralgan three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.
After:   Auralgan is useful for drying out the canal or relieving discomfort.

Before and after removal of cerumen, a cotton pledget moistened with Auralgan should be inserted into the meatus following instillation.

Note:  Do not rinse dropper after use.

Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly.

Protect the solution from light and heat, and do not use if it is brown or contains a precipitate.

DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.

Auralgan® Otic Solution, in package containing 10 mL bottle with separate dropper-screw cap attachment (NDC 0046-1000-10).

Store at room temperature (approximately 25° C).

Manufactured by:
Ayerst Laboratories Inc.
A Wyeth-Ayerst Company
Philadelphia, PA 19101

Last updated on RxList: 12/8/2004

No Information Provided.

No Information Provided.

Last updated on RxList: 12/8/2004

Discontinue promptly if sensitization or irritation occurs.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No long-term studies in animals or humans have been conducted

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Auralgan. It is also not known whether Auralgan can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Auralgan should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Auralgan is administered to a nursing woman.

Last updated on RxList: 12/8/2004

No Information Provided.

Hypersensitivity to any of the components or substances related to them.

Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

Last updated on RxList: 12/8/2004

Auralgan combines the hygroscopic property of dehydrated glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and alleviate pain and discomfort in acute otitis media.

Auralgan does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

Last updated on RxList: 12/8/2004

No Information Provided.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ANTIPYRINE/BENZOCAINE - OTIC

(an-tee-PYE-reen/BEN-zoe-kane)

COMMON BRAND NAME(S): Auralgan, Aurodex, Auroto

USES: This medication is used to relieve pain, congestion, and swelling caused by middle ear inflammation (acute otitis media). This medication is also used to help remove earwax. This product contains 2 main medications. Benzocaine is a topical anesthetic that helps to numb the pain. Antipyrine is an analgesic that helps to decrease the pain and inflammation. This product may also contain glycerin, which helps to soften the earwax, and/or zinc acetate, which helps to protect the skin.

HOW TO USE: Use this medication exactly as directed by your doctor.

An antibiotic medication may sometimes be prescribed along with this medication if you also have an infection.

To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person insert the drops if possible. To lower the risk of dizziness, hold the container in your hand for a few minutes to warm it. To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted for about 2 minutes, or insert a soft cotton plug if so directed. You may be instructed by your doctor to moisten the cotton plug with this medication. Repeat for the other ear if so directed. Do not rinse the dropper. Replace the cap after use.

If you are using this medication to help remove earwax, gently rinsing the ear with warm water or using a soft rubber bulb after 2 to 3 days of treatment may help remove any remaining earwax. Consult your doctor or pharmacist about the safe use of an ear bulb.

Do not use in the eye.

Do not use this medication if it is brown or contains particles.

Inform your doctor if your condition persists after a few days of treatment or if it worsens.

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: burning/stinging/redness/new pain in or around the ears.

Tell your doctor immediately if any of these rare but very serious side effects occur: bluish skin, severe tiredness/weakness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to antipyrine, benzocaine, or other ingredients in this product (e.g., glycerin, zinc acetate); or to other ester-type anesthetics (e.g., procaine, tetracaine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: hole in the eardrum (perforated tympanic membrane).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgery.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other ear medications.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another ear problem unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and heat. Keep bottle tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.