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NDC 41415-0050-75 Publix 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g Details
Publix 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g
Publix is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Publix Super Markets Inc. 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: 41415-0050-75Last 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: 41415-0050-75Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine
Product Information
| NDC | 41415-0050 |
|---|---|
| Product ID | 41415-050_c87aa448-0f05-4470-8b3f-af9ff00deacb |
| Associated GPIs | 46100010101820 |
| GCN Sequence Number | 003026 |
| GCN Sequence Number Description | magnesium hydroxide ORAL SUSP 400 MG/5ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 07950 |
| HICL Sequence Number | 001329 |
| HICL Sequence Number Description | MAGNESIUM HYDROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Publix |
| Proprietary Name Suffix | 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 | Publix Super Markets Inc |
| 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 | 2023-12-31 |
Package
Package Images
NDC 41415-0050-75 (41415005075)
| NDC Package Code | 41415-050-75 |
|---|---|
| Billing NDC | 41415005075 |
| Package | 1 TUBE in 1 CARTON (41415-050-75) / 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 0680644c-a466-4038-aed5-1173a14508e8 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
For external use only
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week
Directions
Adults and children 2 years of age and older:
- clean the affected area and dry thoroughly
- apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Children under 2 years of age: consult a doctor
Other information
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| PUBLIX
ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment |
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| Labeler - Publix Super Markets Inc (006922009) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(41415-050) | |