| Product NDC: | 65517-0009 | 
| Proprietary Name: | Prep Solution | 
| Non Proprietary Name: | POVIDONE-IODINE | 
| Active Ingredient(s): | 1.2 mL/100mL & nbsp; POVIDONE-IODINE | 
| Administration Route(s): | TOPICAL | 
| Dosage Form(s): | SOLUTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 65517-0009 | 
| Labeler Name: | Dukal Corporation | 
| Product Type: | HUMAN OTC DRUG | 
| FDA Application Number: | part333 | 
| Marketing Category: | OTC MONOGRAPH FINAL | 
| Start Marketing Date: | 20100101 | 
| Package NDC: | 65517-0009-2 | 
| Package Description: | 59 mL in 1 BOTTLE, SPRAY (65517-0009-2) | 
| NDC Code | 65517-0009-2 | 
| Proprietary Name | Prep Solution | 
| Package Description | 59 mL in 1 BOTTLE, SPRAY (65517-0009-2) | 
| Product NDC | 65517-0009 | 
| Product Type Name | HUMAN OTC DRUG | 
| Non Proprietary Name | POVIDONE-IODINE | 
| Dosage Form Name | SOLUTION | 
| Route Name | TOPICAL | 
| Start Marketing Date | 20100101 | 
| Marketing Category Name | OTC MONOGRAPH FINAL | 
| Labeler Name | Dukal Corporation | 
| Substance Name | POVIDONE-IODINE | 
| Strength Number | 1.2 | 
| Strength Unit | mL/100mL | 
| Pharmaceutical Classes |