Bacitracin

Overview

Bacitracin is a combination of at least 9 bacitracins. 60-80% of commercially prepared bacitracin is bacitracin A. The bacillus that produces bacitracin was first isolated from a knee scrape in 1945 from the knee wound of a child named Margaret Tracy. Bacitracin was granted FDA approval on 29 July 1948.

Indication

Bacitracin is indicated in topical formulations for acute and chronic localized skin infections. Occasionally, it is also used intramuscularly for infantile streptococcal pneumonia and empyema. Bacitracin is also formulated as an ointment with neomycin and polymyxin B for over the counter use. A bacitracin ointment formulated with neomycin and polymyxin B along with hydrocortisone is indicated for the treatment of corticosteroid responsive dermatoses with secondary infection.

Associated Conditions

Acne
Bacterial Infections of the Intestine
Empyema
Eye Infections
Infection
Inflammatory Reaction caused by Acne
Ocular Inflammatory Disease
Pneumonia
Skin Ulcer
Wound
Wound Infections
Corticosteroid-responsive dermatoses
Infection in minor cuts, scrapes, or burns

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown	2019/04/26	NCT03929224	Phase 4	Completed	Ascension South East Michigan
Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy	2017/07/11	NCT03213249	Phase 1	Completed	Washington University School of Medicine
Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns	2016/02/03	NCT02673229	Phase 4	Terminated	University of Kansas Medical Center
Comparison of Wound Bed Establishment in Facial Burns	2012/08/17	NCT01668030	Phase 4	Completed	University of Louisville
The Relationship of Hemoglobin A1c and Diabetic Wound Healing	2011/05/09	NCT01350102	Phase 4	Terminated	Susan Hassenbein
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge	2010/10/18	NCT01222832	Phase 2	Completed	Steward St. Elizabeth's Medical Center of Boston, Inc.
Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery	2008/06/26	NCT00705354	Not Applicable	Withdrawn	Lahey Clinic
Clinical Evaluation of Bacitracin	2005/08/22	NCT00132600	Phase 2	Completed	Mekos Laboratories AS
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine	2001/08/31	NCT00000635	Not Applicable	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	MWI	13985-608	OPHTHALMIC	400 [USP'U] in 1 g	3/23/2015
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc	Bausch & Lomb Incorporated	24208-780	OPHTHALMIC	400 [USP'U] in 1 g	6/30/2023
Tripleantibioticointmentandpainrelief	Trifecta Pharmaceuticals USA	69396-061	TOPICAL	500 [USP'U] in 100 g	5/12/2025
Bacitracin Zinc and Polymyxin B Sulfate	A-S Medication Solutions	50090-3274	OPHTHALMIC	500 [USP'U] in 1 g	1/31/2023
Neo Polycin HC	Padagis US LLC	0574-4144	OPHTHALMIC	400 [USP'U] in 1 g	11/9/2018
Triple Antibiotic	Phoenix Pharmaceutical, Inc.	57319-343	OPHTHALMIC	400 [USP'U] in 1 g	9/30/2010
polycin	RPK Pharmaceuticals, Inc.	53002-9270	OPHTHALMIC	500 [USP'U] in 1 g	11/12/2018
NEO-POLY-BAC HYDRO	Butler Animal Health Supply	11695-1406	OPHTHALMIC	400 [USP'U] in 1 g	10/5/2010
BACITRACIN ZINC AND POLYMYXIN B SULFATE	Direct_Rx	72189-017	OPHTHALMIC	500 [USP'U] in 1 g	7/24/2019
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc	MWI	13985-607	OPHTHALMIC	400 [USP'U] in 1 g	3/23/2015

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
BANEOCIN POWDER	PHARMAZEUTISCHE FABRIK MONTAVIT GMBH	SIN00678P	POWDER	250 iu/g	5/3/1988
POLYBAMYCIN OINT.	SHIN POONG PHARMACEUTICAL CO LTD	SIN04413P	OINTMENT	400 u/g	5/3/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
BACITIN OINT 500UNITS/G	N/A	TRENTON-BOMA LIMITED	N/A	N/A	9/25/1996

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ANTIBIOTIC OINTMENT USP	Taro Pharmaceuticals Inc	02230251	Ointment - Topical	500 UNIT / G	6/10/2002
ANTIBIOTIC OINTMENT	ksl pharmaceuticals	01978381	Ointment - Topical	500 UNIT / G	12/31/1985
TRIPLE ANTIBIOTIC OINTMENT	cellchem pharmaceuticals inc.	02297949	Ointment - Topical	500 UNIT / G	12/23/2009
BACITRACIN USP	Pfizer Canada Ulc	00030708	Powder For Solution - Intramuscular , Topical	50000 UNIT / VIAL	12/31/1951
BACITRACIN ANTIBIOTIC	Water-Jel Technologies, LLC	02369214	Ointment - Topical	500 UNIT / G	N/A
POLYSPORIN ANTIBIOTIC OINTMENT	johnson & johnson inc	02237227	Ointment - Topical	500 UNIT / G	8/13/1998
POLY ANTIBIOTIC OINTMENT	the avon company canada limited	02510383	Ointment - Topical	500 UNIT / G	3/3/2021
ORIGINAL BACITRAYCIN	first aid research corporation	02283050	Cream - Topical	500 UNIT / G	N/A
ANTIBIOTIC OINTMENT	Jamp Pharma Corporation	02283425	Ointment - Topical	500 UNIT / G	10/28/2006
ANTIBIOTIC OINTMENT	wes pak products ltd.	02229978	Ointment - Topical	500 UNIT / G	4/1/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TRUTEST 36 APOSITO ADHESIVO PARA PRUEBA DE PROVOCACION CON ALERGENOS	Smartpractice Denmark Aps	85395	APÓSITO ADHESIVO PARA PRUEBA DE PROVOCACIÓN CON ALERGENOS	Medicamento Sujeto A Prescripción Médica	Commercialized
POMADA ANTIBIOTICA LIADE	Laboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.R.L.	45656	POMADA	Medicamento Sujeto A Prescripción Médica	Commercialized
PHONAL COMPRIMIDOS PARA CHUPAR	Laboratorio Reig Jofre, S.A.	39071	COMPRIMIDO PARA CHUPAR	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LIZIPAINA	Sanofi Aventis S.A.	46699	COMPRIMIDO PARA CHUPAR	Sin Receta	Not Commercialized
BANEDIF POMADA	Maxfarma, S.A.	25516	POMADA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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