Sheffield Triple Antibiotic 400 [USP'U]/g

Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate · OINTMENT · Sheffield Pharmaceuticals LLC

1 Recall on Record

Plain English

Sheffield Triple Antibiotic is a ointment containing bacitracin zinc, polymyxin b sulfate, neomycin sulfate at 400 [USP'U]/g, taken topical. Manufactured by Sheffield Pharmaceuticals LLC.

Key Facts

Brand Name: Sheffield Triple Antibiotic
Generic Name: Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate
NDC Code (Product): 11527-162
Manufacturer: Sheffield Pharmaceuticals LLC
Strength: 400 [USP'U]/g
Dosage Form: OINTMENT
Route: TOPICAL
Marketing Status
Application #: M004
Marketing Start: 01/23/2011

Recall History

1 Recall 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

Side Effects Reported to FDA

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

rash2 reports

rash erythematous2 reports

application site pain1 reports

application site pruritus1 reports

application site rash1 reports

application site scar1 reports

application site swelling1 reports

blister1 reports

expired product administered1 reports

facial pain1 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 (equal to surface area of tip of finger) on the area 1 to 3 times daily. may be covered with a sterile bandage

Warnings

Warnings For external use only Allergy alert: do not use if you are allergic to any of the ingredients Do not use in or near the eyes on large areas of the body Consult a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use longer than 1 week Stop use and consult a doctor if condition persists or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction develops Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Frequently Asked Questions

What is Sheffield Triple Antibiotic used for?

Sheffield Triple Antibiotic contains Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate. It is a ointment taken topical. Consult your doctor for specific uses.

Is Sheffield Triple Antibiotic a controlled substance?

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

What is the generic name for Sheffield Triple Antibiotic?

The generic name for Sheffield Triple Antibiotic is Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate. There are 6 other brand versions of Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate.

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

The NDC (National Drug Code) for Sheffield Triple Antibiotic 400 [USP'U]/g is 11527-162, listed by Sheffield Pharmaceuticals LLC.

Product NDC

11527-162

Package NDC

11527-162-47

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

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