Pinnacaine Ear Drops

General

Medication should be discontinued if sensitivity or irritation occurs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies of animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy

Pregnancy Category C:

There are no adequate and well-controlled studies in pregnant women. This product should only be given to pregnant women if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Caution should be used when administered to nursing women.

Pediatric Use

Do not use in infants under 1 year of age.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this drug is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Pinnacaine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.