Discontinue promptly if sensitization or irritation occurs.

It is recommended that the following precautions be observed in prescribing and administration of this agent:

1. Extreme caution is indicated in patients with demonstrable dermatologic idiosyncrasies or with history of allergic reactions in general.

2. Exposure of the ear canal to the CERUMENEX Eardrops should be limited to 15-30 minutes.

3. When administering CERUMENEX Eardrops, care must be taken to avoid undue exposure of the skin outside the ear during the instillation and the flushing out of the medication. If the medication comes in contact with the skin, the area should be washed with soap and water. Use of proper technique (see DOSAGE AND ADMINSITRATION) will help avoid such undue exposure.

4. CERUMENEX Eardrops should be used only with caution in external otitis.

Information for Patients

1. Patients should be cautioned to avoid placing the applicator tip into the ear canal.

2. Patients should be cautioned to gently flush the ear with lukewarm water.

3. Patients should be warned to use CERUMENEX Eardrops in ears only. Surrounding skin should be promptly rinsed of any excess drops.

4. Patients should be instructed not to leave CERUMENEX Eardrops in the ear for longer than 30 minutes. A second application may be made, if needed, but more frequent use must be indicated by the physician.

5. Patients must be instructed not to exceed the time of exposure, nor to use the medication more frequently than directed by the physician.

6. Patients should be advised to discontinue the use of the medication in case of a possible reaction and to consult their physician promptly.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of CERUMENEX Eardrops.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not yet been conducted with CERUMENEX Eardrops. It is also not known whether CERUMENEX Eardrops can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CERUMENEX Eardrops 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 CERUMENEX Eardrops are administered to a nursing mother.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

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