Double Antibiotic — Ointment

Overview

Brand name

Double Antibiotic

Generic name

Bacitracin Zinc and Polymyxin B Sulfate

Dosage form

Ointment

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

Encube Ethicals, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

4

NDC product codes

4

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 Zinc	400 [USP'U]/g	204602	View
Bacitracin Zinc	500 [USP'U]/g	204602	View
Polymyxin B Sulfate	10000 [USP'U]/g	204602	View
Polymyxin B Sulfate	5000 [USP'U]/g	204602	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Ointment

Route of administration

Topical

Presentations

10

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
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 20260204). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260204 HUMAN OTC DRUG · 20250930 HUMAN OTC DRUG · 20250701

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Active ingredient (in each gram) Purpose Bacitracin Zinc 500 units First Aid Double Antibiotic Polymyxin B 10,000 units First Aid Double Antibiotic

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 Allergy alert Do not use if allergic to any of the ingredients Do not use in the eyes over large areas of the body longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if the 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

Do Not Use

openFDA Drug Labeling

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

openFDA Drug Labeling

Ask a doctor before use if you have ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not use longer than 1 week unless directed by a doctor

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each gram) Purpose Bacitracin Zinc 500 units First Aid Double Antibiotic Polymyxin B 10,000 units First Aid Double 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
21922-092-05	21922-092	Encube Ethicals, Inc.	1 TUBE in 1 TUBE (21922-092-05) / 28 g in 1 TUBE	March 6, 2025
70677-1212-1	70677-1212	STRATEGIC SOURCING SERVICES LLC	1 TUBE in 1 CARTON (70677-1212-1) / 28.4 g in 1 TUBE	December 15, 2023
58980-012-01	58980-012	STRATUS PHARMACEUTICALS INC	144 PACKET in 1 BOX (58980-012-01) / .9 g in 1 PACKET	September 15, 2017
58980-012-05	58980-012	STRATUS PHARMACEUTICALS INC	1 TUBE in 1 BOX (58980-012-05) / 14.2 g in 1 TUBE	February 8, 2021
58980-012-10	58980-012	STRATUS PHARMACEUTICALS INC	1 TUBE in 1 BOX (58980-012-10) / 28.35 g in 1 TUBE	January 26, 2026
51672-2044-2	51672-2044	Sun Pharmaceutical Industries, Inc.	1 TUBE in 1 CARTON (51672-2044-2) / 28.4 g in 1 TUBE	September 6, 2018
21922-092	21922-092	Encube Ethicals, Inc.	—	March 6, 2025
70677-1212	70677-1212	STRATEGIC SOURCING SERVICES LLC	—	December 15, 2023
58980-012	58980-012	STRATUS PHARMACEUTICALS INC	—	September 15, 2017
51672-2044	51672-2044	Sun Pharmaceutical Industries, Inc.	—	December 5, 1990

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.