| NDC Code | 
                    67877-269-11 | 
                
                
                    | Proprietary Name | 
                    Pramoxine-HC | 
                
                
                    | Package Description | 
                    10 mL in 1 BOTTLE, DROPPER (67877-269-11)  | 
                
                
                    | Product NDC | 
                    67877-269 | 
                
                
                    | Product Type Name | 
                    HUMAN PRESCRIPTION DRUG | 
                
                
                    | Non Proprietary Name | 
                    Hydrocortisone / Chloroxylenol / Pramoxine HCl | 
                
                
                    | Dosage Form Name | 
                    SOLUTION/ DROPS | 
                
                
                    | Route Name | 
                    AURICULAR (OTIC) | 
                
                
                    | Start Marketing Date | 
                    20110926 | 
                
                
                    | Marketing Category Name | 
                    UNAPPROVED DRUG OTHER | 
                
                
                    | Labeler Name | 
                    Ascend Laboratories, LLC | 
                
                
                    | Substance Name | 
                    CHLOROXYLENOL; HYDROCORTISONE; PRAMOXINE HYDROCHLORIDE | 
                
                
                    | Strength Number | 
                    1; 10; 10 | 
                
                
                    | Strength Unit | 
                    mg/mL; mg/mL; mg/mL | 
                
                
                    | Pharmaceutical Classes | 
                    Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |