Drugplain

Antibiotic 3.5 mg/g

neomycin sulfate · OINTMENT · Total Resources International

10 Recalls on Record
Plain English

Antibiotic is a ointment containing neomycin sulfate at 3.5 mg/g, taken topical. Manufactured by Total Resources International.

Key Facts

Brand Name
Antibiotic
Generic Name
neomycin sulfate
NDC Code (Product)
55550-730
Manufacturer
Total Resources International
Strength
3.5 mg/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M004
Marketing Start
10/07/2019

Recall History

10 Recalls on Record
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

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 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 II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective4,173 reports
pain3,658 reports
nausea3,435 reports
fatigue3,245 reports
off label use3,107 reports
headache3,035 reports
dyspnoea2,548 reports
pneumonia2,295 reports
diarrhoea2,198 reports
vomiting2,123 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 Antibiotic used for?

Antibiotic contains neomycin sulfate. It is a ointment taken topical. Consult your doctor for specific uses.

Is Antibiotic a controlled substance?

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

What is the generic name for Antibiotic?

The generic name for Antibiotic is neomycin sulfate. There are 12 other brand versions of neomycin sulfate.

What is the NDC code for Antibiotic 3.5 mg/g?

The NDC (National Drug Code) for Antibiotic 3.5 mg/g is 55550-730, listed by Total Resources International.