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Indication

INTRAROSA vaginal inserts are a prescription medicine used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.

Important Risk Information

Do not use INTRAROSA vaginal inserts if you have vaginal bleeding that has not been checked by your healthcare provider.

Before using INTRAROSA vaginal inserts, tell your healthcare provider about all of your medical conditions, including if you:

• Have, have had, or think you may have had breast cancer. Prasterone, an ingredient in INTRAROSA vaginal inserts, is changed in your body to estrogen. Estrogen medicines are not for use in women who have, have had, or think they may have had breast cancer.

The most common side effects of INTRAROSA vaginal inserts are vaginal discharge and changes on Pap smear.

These are not all of the possible side effects of INTRAROSA vaginal inserts.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

Please see Patient Information in full Prescribing Information.