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City Deerfield / / Company Astellas Pharma Manufacturing Inc. / Astellas Pharma US Inc. / Astellas Pharma / Inc. / / Country United States / / / Event FDA Phase / / Facility I store PROTOPIC Ointment / Store PROTOPIC Ointment / / / IndustryTerm skin application site / drug product / topical applications / skin products / healthcare / mineral oil / / MedicalCondition vaginitis / atopic dermatitis / herpes zoster / shingles / arthritis / bursitis / osteomyelitis / stomatitis / neonatal hyperkalemia / gastrointestinal disorder / Netherton’s Syndrome / superficial skin infections / Sometimes other skin diseases / tendon disorder / bone disorder / severe disease / renal dysfunction / cramps / nail disorder / tumor / pediatric atopic dermatitis / cancer / cystitis / neoplasm / hypothyroidism / CNS Seizures Neoplasms Lymphomas / chills / Carcinogenesis / eczema / Ear Pain / muscle pain / lymphomas / itching / varicella zoster / chronic topical dosing / viral infections / moniliasis / skin disease / lymphadenopathy resolves / benign / oral moniliasis / infection / joint disorder / drug-related tumors / dizziness / renal failure / rash / lung disorder / acute renal failure / herpes simplex virus infection / hypercholesterolemia / adult atopic dermatitis / eczema herpeticum / basal cell carcinoma / chest pain / lymphoma / warts / headache / undifferentiated lymphoma / generalized erythroderma / common cold / chicken pox / severe atopic dermatitis / seborrhea / herpes / cold sores / ear disorder / colitis / cataract NOS / pleomorphic lymphoma / syncope / malignant melanoma Infections Bullous impetigo / lymphadenopathy / gastritis / skin infections / laryngitis / tachycardia / hypersensitivity / constipation / short-term and non-continuous chronic treatment / pruritus / neck pain / infections / Rash† Abdominal Pain Fungal Dermatitis Gastroenteritis Alcohol Intolerance† Acne / rectal disorder / hepatic insufficiency / vaginal moniliasis / epistaxis / cutaneous T-cell lymphoma / valvular heart disease / squamous cell carcinoma / acne / skin infection / dyspnea / furunculosis / otitis externa / acute infectious mononucleosis / vertigo / migraine / skin ulcer / erythema / skin tumor / hernia / Pain / renal insufficiency / ADVERSE REACTIONS No phototoxicity / erythrodermic disease / eye pain / breast neoplasm / Back Pain† Peripheral Edema Varicella Zoster/ Herpes Zoster / skin carcinoma / skin tumors / vesiculobullous rash / cutaneous moniliasis / varicella zoster virus infection / anemia / abscess / blepharitis / dehydration / / MedicalTreatment light therapy / vaccination / radiation / immunosuppression / kidney transplant / antibiotic therapy / liver transplant / / Organization INDICATIONS AND USAGE / and DOSAGE AND ADMINISTRATION / DOSAGE AND ADMINISTRATION / FDA / U.S. Food and Drug Administration / / Person M. Joyce Rico / / / Position Vice President / Medical Sciences See / physician / General / PRECAUTIONS General / pharmacist for more information / pharmacist / Studies Physician / / Product itraconazole / Protopic / erythromycin / cimetidine / fluconazole / ketoconazole / hydrocortisone / Clinical Vehicle PROTOPIC Response Ointment Ointment / Pediatric / PROTOPIC Ointment / / ProvinceOrState New York / Illinois / / PublishedMedium the Medication Guide / / Technology radiation / alpha / Pharmacokinetics / DNA synthesis / / URL www.protopic.com / www.fda.gov/medwatch / / SocialTag 
January[removed]Protopic Dear Healthcare Provider Letter