| 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 |