First Aid Antibiotic 400 U/g

BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE · LIQUID · Hubei Fanjian Medical Product Co.,Ltd

6 Recalls on Record

Plain English

First Aid Antibiotic is a liquid containing bacitracin zinc, neomycin sulfate, polymyxin b sulfate at 400 U/g, taken topical. Manufactured by Hubei Fanjian Medical Product Co.,Ltd.

Key Facts

Brand Name: First Aid Antibiotic
Generic Name: BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
NDC Code (Product): 83165-005
Manufacturer: Hubei Fanjian Medical Product Co.,Ltd
Strength: 400 U/g
Dosage Form: LIQUID
Route: TOPICAL
Marketing Status
Application #: M004
Marketing Start: 01/01/2023

Recall History

6 Recalls on Record

Class II06/08/2017

Phillips Co.

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

TerminatedVoluntary: Firm initiated

Class II06/08/2017

Phillips Co.

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

TerminatedVoluntary: 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 II06/08/2017

Phillips Co.

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

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 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 hypersensitivity946 reports

off label use596 reports

drug ineffective562 reports

pain547 reports

nausea461 reports

dyspnoea401 reports

rash364 reports

malaise323 reports

vomiting322 reports

pneumonia302 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses first aid to help prevent infection in minor: • cuts • scrapes • 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 • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • 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. (1-800-222-1222)

Frequently Asked Questions

What is First Aid Antibiotic used for?

First Aid Antibiotic contains BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE. It is a liquid taken topical. Consult your doctor for specific uses.

Is First Aid Antibiotic a controlled substance?

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

What is the generic name for First Aid Antibiotic?

The generic name for First Aid Antibiotic is BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE. There are 11 other brand versions of BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE.

What is the NDC code for First Aid Antibiotic 400 U/g?

The NDC (National Drug Code) for First Aid Antibiotic 400 U/g is 83165-005, listed by Hubei Fanjian Medical Product Co.,Ltd.

Product NDC

83165-005

Package NDC

Other Bacitracin Brands

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

Data from openFDA · Public domain (CC0 1.0)