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1 Indications And Usage • Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Is Indicated For Adjunctive Treatment Of Diaper Dermatitis When Complicated By Documented Candidiasis (Microscopic Evidence Of Pseudohyphae And/or Budding Yeast) In Immunocompetent Pediatric Patients 4 Weeks And Older. ( 1.1 ) • Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Should Not Be Used As A Substitute For Frequent Diaper Changes. ( 1.1 ) • Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Should Not Be Used To Prevent The Occurrence Of Diaper Dermatitis, Since Preventative Use May Result In The Development Of Drug Resistance. ( 1.2 ) 1.1 Indication Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Is Indicated For The Adjunctive Treatment Of Diaper Dermatitis Only When Complicated By Documented Candidiasis (Microscopic Evidence Of Pseudohyphae And/or Budding Yeast), In Immunocompetent Pediatric Patients 4 Weeks And Older. A Positive Fungal Culture For Candida Albicans Is Not Adequate Evidence Of Candidal Infection Since Colonization With C. Albicans Can Result In A Positive Culture. The Presence Of Candidal Infection Should Be Established By Microscopic Evaluation Prior To Initiating Treatment. Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Should Be Used As Part Of A Treatment Regimen That Includes Measures Directed At The Underlying Diaper Dermatitis, Including Gentle Cleansing Of The Diaper Area And Frequent Diaper Changes. Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Should Not Be Used As A Substitute For Frequent Diaper Changes. 1.2 Limitations Of Use The Safety And Efficacy Of Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Have Not Been Demonstrated In Immunocompromised Patients, Or In Infants Less Than 4 Weeks Of Age (Premature Or Term). The Safety And Efficacy Of Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Have Not Been Evaluated In Incontinent Adult Patients. Miconazole Nitrate, Zinc Oxide And White Petrolatum Ointment Should Not Be Used To Prevent The Occurrence Of Diaper Dermatitis, Such As In An Adult Institutional Setting, Since Preventative Use May Result In The Development Of Drug Resistance.
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