Triple Antibiotic

POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE TOPICAL HUMAN OTC DRUG

Triple Antibiotic is an FDA drug label for the active ingredient POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE manufactured by Cosette Pharmaceuticals, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231220.

Generic name
POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE
Manufacturer
Cosette Pharmaceuticals, Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
0713-0268
Application
M004
Label effective
20231220

Active ingredients

ACTIVE INGREDIENT (in each gram) Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units

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

Contraindications

Not available.

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 • longer than 1 week unless directed by a doctor Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • the condition persists or gets worse • a rash or other allergic reaction develops

Adverse Reactions

Not available.