"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
XERESE (acyclovir and hydrocortisone cream) 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).
DOSAGE AND ADMINISTRATION
Topically apply XERESE (acyclovir and hydrocortisone cream) 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear).
For each dose, topically apply a quantity of XERESE (acyclovir and hydrocortisone cream) sufficient to cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. For adolescents 12 years of age and older, the dosage is the same as in adults.
Dosage Forms And Strengths
Each gram of XERESE (acyclovir and hydrocortisone cream) contains 5% (w/w) acyclovir and 1% (w/w) hydrocortisone in an aqueous cream base.
XERESE (acyclovir and hydrocortisone cream) is supplied in plastic-laminated aluminum tubes containing 2 gm or 5 gm of XERESE (acyclovir and hydrocortisone cream) . Each gram of XERESE (acyclovir and hydrocortisone cream) contains 5% (w/w) acyclovir and 1% (w/w) hydrocortisone in an aqueous cream base.
NDC XXXXX-XXX-XXX: 2-gm tubes
NDC XXXXX-XXX-XXX: 5-gm tubes
Store at Controlled Room Temperature [20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.]
Manufactured for: Medivir AB, PO Box 1086 SE-141 22 Huddinge SWEDEN. Manufactured by: Contract Pharmaceuticals Limited, 7600 Danbro Crescent Mississauga, Ontario CANADA L5N 6L6. Revised: 05/2010.
Last reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Xerese Information
Report Problems to the Food and Drug Administration
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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