| NDC Code | 54859-504-01 |
|---|
| Package Description | 30 mL in 1 BOTTLE, SPRAY (54859-504-01) |
|---|
| Product NDC | 54859-504 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Orasep |
|---|
| Non-Proprietary Name | Benzocaine, Menthol, Cetylpyridinium Chloride |
|---|
| Dosage Form | LIQUID |
|---|
| Usage | TOPICAL |
|---|
| Start Marketing Date | 20100401 |
|---|
| Marketing Category Name | OTC MONOGRAPH NOT FINAL |
|---|
| Application Number | part356 |
|---|
| Manufacturer | Llorens Pharmaceutical International Division |
|---|
| Substance Name | BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL |
|---|
| Strength | 2; .1; .5 |
|---|
| Strength Unit | mg/100mL; mg/100mL; mg/100mL |
|---|
| Pharmacy Classes | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
|---|