Tripleantibioticointmentandpainrelief

Overview

Brand name

Tripleantibioticointmentandpainrelief

Generic name

Bacitracin,Neomycin,Polymxin, Pramoxine

Dosage form

Ointment

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

Trifecta Pharmaceuticals USA

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

4

NDC product codes

3

Packages

6

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	500 [USP'U]/100g	1648110	View
Neomycin Sulfate	3.5 mg/100g	204602	View
Polymyxin B Sulfate	10000 [USP'U]/100g	204602	View
Pramoxine Hydrochloride	10 mg/100g	1234532	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Ointment

Route of administration

Topical

Presentations

9

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

M

Approval date

July 16, 1969

Sponsor

PHARMICS

Products on application

1

Submissions recorded

3

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 20250512). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250512 HUMAN OTC DRUG · 20241220

Indications and Usage

openFDA Drug Labeling

Uses First Aid to help prevent infection in minor: Cuts Scrapes Burns

Purpose

openFDA Drug Labeling

Purpose First Aid Antibiotic

Purpose External Analgesic

Dosage and Administration

openFDA Drug Labeling

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

Warnings

openFDA Drug Labeling

Warnings For external use only. Do not use: In eyes Over large areas of the body If you are allergic to any of the ingredients

Ask a Doctor

openFDA Drug Labeling

Ask a Doctor before Use Ask Doctor before use if you have: Deep or puncture wouns Animal bites Serious burns

Stop Use

openFDA Drug Labeling

Stop Use and ask a Doctor if: Condition persists or gets worse You need to use longer than 1 week A rash or other allergic reaction develops

Active Ingredient

openFDA Drug Labeling

Active Ingredient Bacitracin zinc 500 Units

Active Ingredient Neomycin Sulfate 3.5mg

Active Ingredient Polymyxin B Sulfate 10,000 Units

Active Ingredient Pramoxine HCL 10mg

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
69396-044-01	69396-044	Trifecta Pharmaceutical USA LLC	1 TUBE in 1 BOX (69396-044-01) / 28.4 g in 1 TUBE	September 22, 2019
69396-030-01	69396-030	Trifecta Pharmaceuticals USA	1 TUBE in 1 BOX (69396-030-01) / 28.4 g in 1 TUBE	July 20, 2017
69396-030-44	69396-030	Trifecta Pharmaceuticals USA	4 TUBE in 1 BOX (69396-030-44) / 30 g in 1 TUBE	October 20, 2024
69396-061-01	69396-061	Trifecta Pharmaceuticals USA	1 TUBE in 1 BOX (69396-061-01) / 28.4 g in 1 TUBE	May 12, 2025
69396-061-22	69396-061	Trifecta Pharmaceuticals USA	2 TUBE in 1 BOX (69396-061-22) / 28.4 g in 1 TUBE	February 3, 2025
69396-061-44	69396-061	Trifecta Pharmaceuticals USA	4 TUBE in 1 BOX (69396-061-44) / 28.4 g in 1 TUBE	February 3, 2025
69396-044	69396-044	Trifecta Pharmaceutical USA LLC	—	August 30, 2019
69396-030	69396-030	Trifecta Pharmaceuticals USA	—	July 20, 2017
69396-061	69396-061	Trifecta Pharmaceuticals USA	—	February 3, 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.