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Single Antibiotic with bacitracin

bacitracin zinc · Ointment

Over-the-counter M Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Single Antibiotic with bacitracin

Generic name

bacitracin zinc

Dosage form

Ointment

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

Safetec of America

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Bacitracin Zinc	400 [USP'U]/g	204602	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Ointment

Route of administration

Topical

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Decreased Cell Wall Synthesis & Repair [PE]	PE	All 41 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

000004

Application type

Approval date

July 16, 1969

Sponsor

PHARMICS

Products on application

Submissions recorded

Products approved under application 000004.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
000004-004	PAREDRINE	SOLUTION/DROPS		HYDROXYAMPHETAMINE HYDROBROMIDE	Discontinued	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 000004.
Type	No.	Action	Status	Date	Review
Supplement	11	Labeling	Approved	May 26, 1987	—
Supplement	10	Labeling	Approved	May 8, 1980	—
Original application	1		Approved	July 16, 1969	Unknown

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241230). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241230

Indications and Usage

openFDA Drug Labeling

Uses: First aid to help prevent infection in minor cuts, scrapes, and burns.

Purpose

openFDA Drug Labeling

Purpose First Aid Antibiotic

Dosage and Administration

openFDA Drug Labeling

Directions: clean affected area apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily may cover with a sterile bandage

Warnings

openFDA Drug Labeling

Warnings: For external use only. Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center directly. Do Not Use: in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if allergic to any of the ingredients Stop use, ask a doctor if: condition persists or gets worse a rash or allergic reaction develops

Do Not Use

openFDA Drug Labeling

Do Not Use: in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if allergic to any of the ingredients

Stop Use

openFDA Drug Labeling

Stop use, ask a doctor if: condition persists or gets worse a rash or allergic reaction develops

Active Ingredient

openFDA Drug Labeling

Active Ingredient (in each gram) Bacitracin zinc (500 units bacitracin)

Adverse event reports

Source: openFDA FAERS

4,395

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: BACITRACIN ZINC. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
52412-750-05	52412-750	Randob Labs Ltd.	1 TUBE in 1 BOX (52412-750-05) / 14 g in 1 TUBE	December 30, 2024
52412-750-10	52412-750	Randob Labs Ltd.	1 TUBE in 1 BOX (52412-750-10) / 28 g in 1 TUBE	December 30, 2024
61010-5601-2	61010-5601	Safetec of America	144 POUCH in 1 BOX (61010-5601-2) / .9 g in 1 POUCH (61010-5601-1)	November 13, 2008
61010-5601-3	61010-5601	Safetec of America	25 POUCH in 1 BOX (61010-5601-3) / .9 g in 1 POUCH (61010-5601-1)	November 13, 2008
52412-750	52412-750	Randob Labs Ltd.	—	December 30, 2024
61010-5601	61010-5601	Safetec of America	—	November 13, 2008

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.