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Suppliers must adhere to Good Manufacturing Practices (GMP), International Organization for Standardization (ISO) standards relevant to cosmetics (e.g., ISO 22716), and regional regulations like the EU Cosmetics Regulation (EC) No 1223/2009 or the FDA's guidelines for cosmetics in the US
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In post-marketing experience, as with other azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena) have been reported in association with increases in prothrombin time in patients receiving fluconazole concurrently with warfarin
