| NDC Code | 76986-025-01 |
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| Package Description | 300 mL in 1 BOTTLE (76986-025-01) |
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| Product NDC | 76986-025 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Gembooxt Ketoconazole 1% Medicated Shampoos |
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| Non-Proprietary Name | Ketoconazole |
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| Dosage Form | LIQUID |
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| Usage | TOPICAL |
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| Start Marketing Date | 20260130 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | 505G(a)(3) |
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| Manufacturer | Guangdong Quadrant Ecological Technology Co., Ltd. |
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| Substance Name | KETOCONAZOLE |
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| Strength | .01 |
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| Strength Unit | g/mL |
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| Pharmacy Classes | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
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