If you see your cold sore as a BIG deal

If you see your cold sore as a BIG deal



You’ll want to
hear the big news
about XERESE

Indication and Important Safety Information

XERESE® (acyclovir and hydrocortisone) Cream 5%/1% is indicated for the early treatment
of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and
to shorten the lesion healing time in adults and adolescents (12 years of age and older).

XERESE Cream is intended for cutaneous use only, on the lips and around the mouth.
XERESE should not be used in the eye, inside the mouth or nose, or on the genitals. Patients
should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.
The effect of XERESE Cream has not been sufficiently established in immunocompromised
patients. XERESE Cream has a potential for irritation and contact sensitization. In clinical
trials, the most common adverse reactions in the area of the application site included drying or
flaking of the skin; burning or tingling following application; erythema; pigmentation changes;
application site reaction including signs and symptoms of inflammation. Each event occurred in
less than 1% of patients.

Indication and Important Safety Information

XERESE (acyclovir and hydrocortisone) Cream 5% /1% is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older).

  • XERESE is for cold sores on lips and around the mouth only and should not be used in eyes, mouth, nose or genitals. Use exactly as directs by your healthcare provider.
  • XERESE is not a cure for cold sores.
  • It is not known if XERESE is safe or works in children younger than 12 years old.
  • The safety of XERESE is unknown in women who are pregnant or breast-feeding, or in patients with a weak immune system (become sick very easily). Tell your healthcare provider about these or any other medical conditions you have before using XERESE.
  • Talk to your healthcare provider if your cold sore is not better in 2 weeks.
  • The most common side effects of XERESE are: drying or flaking of the skin, tingling or burning after applying it, redness of the skin, swelling or changes in skin colour where the cream is applied, and a bitter taste after applying XERESE. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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