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NDC 36800-0056-24 TopCare 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g Details
TopCare 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g
TopCare is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.
Related Packages: 36800-0056-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.
Related Packages: 36800-0056-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine
Product Information
| NDC | 36800-0056 |
|---|---|
| Product ID | 36800-056_046e7bf1-e381-42fe-b5f0-47eea7d9edd9 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | TopCare |
| Proprietary Name Suffix | Triple Antibiotic Plus Pain Relief |
| Non-Proprietary Name | Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 500; 3.5; 10000; 10 |
| Active Ingredient Units | [iU]/g; mg/g; [iU]/g; mg/g |
| Substance Name | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333B |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0056-24 (36800005624)
| NDC Package Code | 36800-056-24 |
|---|---|
| Billing NDC | 36800005624 |
| Package | 1 TUBE in 1 CARTON (36800-056-24) / 28.4 g in 1 TUBE |
| Marketing Start Date | 2012-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0fc0dbc6-ca1d-42be-8016-68e64f119706 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Directions
Other information
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| TOPCARE
TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment |
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| Labeler - Topco Associates LLC (006935977) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(36800-056) | |