Drugplain

Triple Antibiotic 400 [USP'U]/g

Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate. · OINTMENT · ProStat First Aid, LLC.

8 Recalls on Record
Plain English

Triple Antibiotic ointment is a topical antibiotic combination used to help prevent infection in minor cuts, scrapes, and burns. This over-the-counter product contains three antibacterial ingredients that work together to protect small wounds.

Key Facts

Brand Name
Triple Antibiotic
Generic Name
Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.
NDC Code (Product)
58228-7050
Manufacturer
ProStat First Aid, LLC.
Strength
400 [USP'U]/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M004
Marketing Start
01/27/2026

Recall History

8 Recalls on Record
Class II11/22/2013

Faria Limited LLC dba Sheffield Pharmaceuticals

Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

TerminatedVoluntary: Firm initiated
Class II11/22/2013

Faria Limited LLC dba Sheffield Pharmaceuticals

Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class III05/28/2013

Faria Limited LLC dba Sheffield Pharmaceuticals

Failed Stability Specifications: Unable to meet shelf life expiry.

TerminatedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II11/22/2013

Faria Limited LLC dba Sheffield Pharmaceuticals

Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug hypersensitivity350 reports
pain165 reports
nausea133 reports
rash121 reports
fatigue113 reports
drug ineffective112 reports
off label use112 reports
anxiety110 reports
diarrhoea107 reports
renal failure107 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) First aid to help prevent infection in minor cuts, scrapes, and burns

Dosage & Administration

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

Warnings For External Use Only Do not use • In the eyes or apply 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 before use if You have deep or puncture wounds, animal bites, or 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 (1-800-222-1222) right away.

Frequently Asked Questions

What is Triple Antibiotic used for?

Triple Antibiotic ointment is a topical antibiotic combination used to help prevent infection in minor cuts, scrapes, and burns. This over-the-counter product contains three antibacterial ingredients that work together to protect small wounds.

Is Triple Antibiotic a controlled substance?

Triple Antibiotic is not classified as a controlled substance by the DEA.

What is the generic name for Triple Antibiotic?

The generic name for Triple Antibiotic is Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.. There are 1 other brand versions of Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate..

What is the NDC code for Triple Antibiotic 400 [USP'U]/g?

The NDC (National Drug Code) for Triple Antibiotic 400 [USP'U]/g is 58228-7050, listed by ProStat First Aid, LLC..

Product NDC

58228-7050

Package NDC

58228-7050-1

Other Bacitracin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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