| Product NDC: | 57613-009 |
| Proprietary Name: | Prevail-FX One Step |
| Non Proprietary Name: | povidone-iodine and isopropyl alcohol |
| Active Ingredient(s): | 725; 83 mg/mL; mg/mL & nbsp; povidone-iodine and isopropyl alcohol |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 57613-009 |
| Labeler Name: | Productos Urologos de Mexico, S.A. de C.V. |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part333A |
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Start Marketing Date: | 19980601 |
| Package NDC: | 57613-009-40 |
| Package Description: | 1 APPLICATOR in 1 POUCH (57613-009-40) > 40 mL in 1 APPLICATOR |
| NDC Code | 57613-009-40 |
| Proprietary Name | Prevail-FX One Step |
| Package Description | 1 APPLICATOR in 1 POUCH (57613-009-40) > 40 mL in 1 APPLICATOR |
| Product NDC | 57613-009 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | povidone-iodine and isopropyl alcohol |
| Dosage Form Name | SOLUTION |
| Route Name | TOPICAL |
| Start Marketing Date | 19980601 |
| Marketing Category Name | OTC MONOGRAPH NOT FINAL |
| Labeler Name | Productos Urologos de Mexico, S.A. de C.V. |
| Substance Name | ISOPROPYL ALCOHOL; POVIDONE-IODINE |
| Strength Number | 725; 83 |
| Strength Unit | mg/mL; mg/mL |
| Pharmaceutical Classes |