Triple Antibiotic Plus

POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL TOPICAL HUMAN OTC DRUG

Triple Antibiotic Plus is an FDA drug label for the active ingredient POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL 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 20231221.

Generic name
POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL
Manufacturer
Cosette Pharmaceuticals, Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
0713-0622
Application
M004
Label effective
20231221

Active ingredients

Active ingredients (in each gram) Purpose Bacitracin zinc 500 units First aid antibiotic Neomycin 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine hydrochloride 10.0 mg Topical analgesic

Indications & Usage

USES first aid to help prevent infection and provide temporary relief of pain or discomfort in minor • cuts • scrapes • burns

Dosage & Administration

DIRECTIONS • adults and children 2 years of age and older • 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 • children under 2 years of age: consult a doctor

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 symptoms persist for more than 1 week, or clear up and occur again within a few days a rash or other allergic reaction develops

Adverse Reactions

Not available.