| NDC Code | 77338-201-01 |
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| Package Description | 1 TUBE in 1 CARTON (77338-201-01) / 9.35 g in 1 TUBE |
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| Product NDC | 77338-201 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Astonea Maximum Strength Oral Pain Relief |
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| Non-Proprietary Name | Benzocaine 20%, Benzalkonium Chloride 1% |
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| Dosage Form | GEL |
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| Usage | TOPICAL |
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| Start Marketing Date | 20220201 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M013 |
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| Manufacturer | ASTONEA LABS PRIVATE LIMITED |
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| Substance Name | BENZALKONIUM CHLORIDE; BENZOCAINE |
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| Strength | 10; 200 |
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| Strength Unit | mg/g; mg/g |
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| Pharmacy Classes | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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