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Triple Antibiotic

Bacitracin ZINC, Neomycin SULFATE, Polymyxin B SULFATE, Polymyxin B · Cream

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
Triple Antibiotic
Generic name
Bacitracin ZINC, Neomycin SULFATE, Polymyxin B SULFATE, Polymyxin B
Dosage form
Cream
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
J&A Digital Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
3
Packages
3
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 [CFU]/g 204602 View
Hydrocortisone 1 g/1 604449 View
Neomycin Sulfate 3.5 mg/g 204602 View
Polymyxin B Sulfate 5000 [CFU]/g 204602 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Topical
Presentations
6

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
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 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@FDANDC 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 20260124). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260124 HUMAN OTC DRUG · 20250807

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 the affected area 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

keep out of reach of children section

Do Not Use

openFDA Drug Labeling

Do not use in eyes over large areas of the body if you are allergic to any of the ingredients 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 puntucre wounds animal bites serious burns

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. Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each gram) Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Adverse event reports

Source: openFDA FAERS
123,956
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: HYDROCORTISONE. 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
82942-1002-1 82942-1002 J&A Digital Inc. .9 g in 1 PACKET (82942-1002-1) October 1, 2022
82942-1004-1 82942-1004 J&A Digital Inc. .9 g in 1 PACKET (82942-1004-1) July 31, 2025
87365-473-17 87365-473 Jiangxi He-Oumei Health Industry Co., Ltd. 5 VIAL, PLASTIC in 1 BOX (87365-473-17) / 1 CREAM in 1 VIAL, PLASTIC January 24, 2026
82942-1002 82942-1002 J&A Digital Inc. — October 1, 2022
82942-1004 82942-1004 J&A Digital Inc. — July 31, 2025
87365-473 87365-473 Jiangxi He-Oumei Health Industry Co., Ltd. — January 24, 2026

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 · 11 sections on this page.