| Product NDC: | 0135-0091 |
| Proprietary Name: | DEBROX |
| Non Proprietary Name: | carbamide peroxide |
| Active Ingredient(s): | .065 mg/mL & nbsp; carbamide peroxide |
| Administration Route(s): | AURICULAR (OTIC) |
| Dosage Form(s): | LIQUID |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0135-0091 |
| Labeler Name: | GlaxoSmithKline Consumer Healthcare LP |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part344 |
| Marketing Category: | OTC MONOGRAPH FINAL |
| Start Marketing Date: | 20101108 |
| Package NDC: | 0135-0091-63 |
| Package Description: | 15 mL in 1 BOTTLE (0135-0091-63) |
| NDC Code | 0135-0091-63 |
| Proprietary Name | DEBROX |
| Package Description | 15 mL in 1 BOTTLE (0135-0091-63) |
| Product NDC | 0135-0091 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | carbamide peroxide |
| Dosage Form Name | LIQUID |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20101108 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Labeler Name | GlaxoSmithKline Consumer Healthcare LP |
| Substance Name | CARBAMIDE PEROXIDE |
| Strength Number | .065 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |