Home Applications 021307 Application 021307
Type NDA
Sponsor BAYER HEALTHCARE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOTRIMIN ULTRA BUTENAFINE HYDROCHLORIDE CREAM;TOPICAL 1% Yes Yes
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021307-001 LOTRIMIN ULTRA BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL RLD, RS 2001-12-07
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
NDC Listings For This Application# NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 11523-0082 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-0082 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-0082 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4338 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4338 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4338 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4338 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4338 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4339 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4339 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-4339 Lotrimin Ultra Butenafine hydrochloride Bayer Healthcare LLC. NDA Current 11523-7154 Lotrimin Ultra Butenafine Hydrochloride Bayer HealthCare LLC. NDA Current 11523-7155 Lotrimin Ultra Jock Itch Butenafine Hydrochloride Bayer HealthCare LLC. NDA Current