Drugplain

First Aid Antibiotic 500 [USP'U]/g

bacitracin zinc · OINTMENT · Medline Industries, LP

6 Recalls on Record
Plain English

First Aid Antibiotic is a ointment containing bacitracin zinc at 500 [USP'U]/g, taken topical. Manufactured by Medline Industries, LP.

Key Facts

Brand Name
First Aid Antibiotic
Generic Name
bacitracin zinc
NDC Code (Product)
53329-089
Manufacturer
Medline Industries, LP
Strength
500 [USP'U]/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M004
Marketing Start
03/01/2010

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. It is a ointment 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. There are 11 other brand versions of bacitracin zinc.

What is the NDC code for First Aid Antibiotic 500 [USP'U]/g?

The NDC (National Drug Code) for First Aid Antibiotic 500 [USP'U]/g is 53329-089, listed by Medline Industries, LP.