triethanolamine polypeptide oleate - otic, Cerumenex (cont.)

HOW TO USE: This medication is for use only in the ear as directed by your doctor. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person give 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 fill the ear canal with the drops. 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. Insert a soft cotton plug in the ear and leave it in for 15 to 20 minutes. After this time, remove the plug and gently flush the ear with warm water using an ear syringe with a soft rubber bulb.Do not rinse the dropper. Replace the dropper cap after use.Avoid getting any of the medication on the skin outside the ear because it can be irritating. If this occurs, wash the area with soap and water.Avoid getting this medication in your eyes. If this occurs, rinse the eyes thoroughly with water.Do not keep this medication in the ear for longer than 20 minutes or use it more often than directed.If the earwax remains, talk to your doctor before re-using. If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

SIDE EFFECTS: This medication may cause a temporary burning feeling in your ear for 1 to 2 minutes when it is first applied. If this effect persists or worsens, contact your doctor or pharmacist promptly.A very serious allergic reaction to this drug is rare. However, stop using this medication and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), ear pain, 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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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