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Thera Plus Original Strength Triple Antibiotic

Bacitracin ZINC, Neomycin SULFATE, Polymyxin B Sulfate · 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

Thera Plus Original Strength Triple Antibiotic

Generic name

Bacitracin ZINC, Neomycin SULFATE, Polymyxin B Sulfate

Dosage form

Ointment

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

Fourstar Group USA, Inc

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 U/g	204602	View
Neomycin Sulfate	3.5 mg/g	204602	View
Polymyxin B Sulfate	5000 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
Aminoglycoside Antibacterial [EPC]	EPC	All 66 members
Aminoglycosides [CS]	CS	All 66 members
Decreased Cell Wall Synthesis & Repair [PE]	PE	All 41 members
Polymyxin-class Antibacterial [EPC]	EPC	All 55 members
Polymyxins [CS]	CS	All 55 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 20251202). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251202

Indications and Usage

openFDA Drug Labeling

Uses for first aid to help to prevent infection in minor: • cuts • scrapes • burns

Purpose

openFDA Drug Labeling

Purpose First aid antibiotic

Dosage and Administration

openFDA Drug Labeling

Directions • Adults and children 2 years of age and older: • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) to affected area 1 to 3 times daily • may be covered with a sterile bandage. • children under 2 years of age: ask a doctor before use

Warnings

openFDA Drug Labeling

Warnings For external use only. Do not use • if you are allergic to any of the ingredients in this product • in contact with the eyes or mucous membranes • over large areas of the body • longer than 1 week unless directed by a doctor When using this product avoid contact with eyes Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • symptoms last for more than 7 days • the conditions persists or gets worse • symptoms clear up and the occur again within a few days • a rash or other allergic reaction occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use • if you are allergic to any of the ingredients in this product • in contact with the eyes or mucous membranes • over large areas of the body • longer than 1 week unless directed by a doctor

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • symptoms last for more than 7 days • the conditions persists or gets worse • symptoms clear up and the occur again within a few days • a rash or other allergic reaction occurs

Active Ingredient

openFDA Drug Labeling

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

Adverse event reports

Source: openFDA FAERS

4,875

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: POLYMYXIN B SULFATE. 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
80684-140-00	80684-140	FOURSTAR GROUP USA, INC.	14 g in 1 TUBE (80684-140-00)	March 3, 2025
80684-198-00	80684-198	Fourstar Group USA, Inc	6 PACKET in 1 BOX (80684-198-00) / .9 g in 1 PACKET	November 20, 2025
80684-140	80684-140	FOURSTAR GROUP USA, INC.	—	March 3, 2025
80684-198	80684-198	Fourstar Group USA, Inc	—	November 20, 2025

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.