Topcare Antibiotic is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Pramoxine Hydrochloride.
| Product ID | 36800-976_1da253a6-ba2e-4cc8-8e32-d33944870f99 |
| NDC | 36800-976 |
| Product Type | Human Otc Drug |
| Proprietary Name | Topcare Antibiotic |
| Generic Name | Neomycin, Polymyxin B, Pramoxine Hydrochloride |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2020-04-03 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part333B |
| Labeler Name | Topco Associates LLC |
| Substance Name | NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE |
| Active Ingredient Strength | 4 mg/g; [USP'U]/g; mg/g |
| Pharm Classes | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2020-04-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part333B |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-03 |
| Ingredient | Strength |
|---|---|
| NEOMYCIN SULFATE | 3.5 mg/g |
| SPL SET ID: | 8c349cac-20e1-4600-9b0a-fcfe929551c5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36800-976 | Topcare Antibiotic | neomycin, polymyxin B, pramoxine hydrochloride |
| 69842-754 | Antibiotic and Pain Relief | neomycin, polymyxin B, pramoxine hydrochloride |
| 30142-790 | antibiotic plus pain relief | Neomycin, Polymyxin B, Pramoxine Hydrochloride |