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NDC 41415-0049-75 Publix 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g Details

Publix 400; 3.5; 5000 [iU]/g; mg/g; [iU]/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.

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: 41415-0049-75
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	41415-0049
Product ID	41415-049_5aee3a54-1338-4cc0-bef8-10733e4986c7
Associated GPIs	41200020400305 90109803104200
GCN Sequence Number	011655
GCN Sequence Number Description	clemastine fumarate TABLET 1.34 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	46690
HICL Sequence Number	004512
HICL Sequence Number Description	CLEMASTINE FUMARATE
Brand/Generic	Generic
Proprietary Name	Publix
Proprietary Name Suffix	antibiotic
Non-Proprietary Name	Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400; 3.5; 5000
Active Ingredient Units	[iU]/g; mg/g; [iU]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
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 41415-0049-75 (41415004975)

Pricing Information	N/A
NDC Package Code	41415-049-75
Billing NDC	41415004975
Package	1 TUBE in 1 CARTON (41415-049-75) / 28.4 g in 1 TUBE
Marketing Start Date	1995-12-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c787f5df-eee3-485e-8d43-01ba2113930d Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 400 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 5,000 units	First aid antibiotic

Uses

first aid to help prevent infection in

minor cuts
scrapes
burns

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

Ask a doctor before use

on deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

condition persists or gets worse
a rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

To open: unscrew cap, pull tab to remove foil seal
store at room temperature
see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Publix

antibioticointment

POLYMYXIN B SULFATE • BACITRACIN ZINC • NEOMYCIN SULFATE

FIRST AID ANTIBIOTIC OINTMENT

• helps prevent infection in minor cuts, scrapes, and burns.

NET WT 1 OZ (28.4g)

Principal Display Panel - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

PUBLIX ANTIBIOTIC

bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41415-049
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	400 [iU] in 1 g
Neomycin sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg in 1 g
Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	5000 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41415-049-75	1 in 1 CARTON	12/14/1995
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333B	12/14/1995

Labeler - Publix Super Markets Inc (006922009)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(41415-049)

Revised: 12/2021

Document Id: 5aee3a54-1338-4cc0-bef8-10733e4986c7

Set id: c787f5df-eee3-485e-8d43-01ba2113930d

Version: 2

Effective Time: 20211214

Search by Drug Name or NDC

NDC 41415-0049-75 Publix 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g Details

Publix 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 41415-0049-75 (41415004975)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c787f5df-eee3-485e-8d43-01ba2113930d Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use

Stop use and ask a doctor if

Directions

Other information

Inactive ingredient

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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