TRIPLE ANTIBIOTIC 500 [USP'U]/g
Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl · OINTMENT · Encube Ethicals, Inc.
TRIPLE ANTIBIOTIC is a ointment containing bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl at 500 [USP'U]/g, taken topical. Manufactured by Encube Ethicals, Inc..
Key Facts
- Brand Name
- TRIPLE ANTIBIOTIC
- Generic Name
- Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl
- NDC Code (Product)
21922-101- Manufacturer
- Encube Ethicals, Inc.
- Strength
- 500 [USP'U]/g
- Dosage Form
- OINTMENT
- Route
- TOPICAL
- Marketing Status
- Application #
- M004
- Marketing Start
- 03/06/2025
Recall History
Faria Limited LLC dba Sheffield Pharmaceuticals
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Faria Limited LLC dba Sheffield Pharmaceuticals
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Faria Limited LLC dba Sheffield Pharmaceuticals
Failed Stability Specifications: Unable to meet shelf life expiry.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
KENIL HEALTHCARE PRIVATE LIMITED
CGMP Deviations
Faria Limited LLC dba Sheffield Pharmaceuticals
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Product Quest Manufacturing LLC
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 TRIPLE ANTIBIOTIC used for?
TRIPLE ANTIBIOTIC contains Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl. It is a ointment taken topical. Consult your doctor for specific uses.
Is TRIPLE ANTIBIOTIC a controlled substance?
TRIPLE ANTIBIOTIC is not classified as a controlled substance by the DEA.
What is the generic name for TRIPLE ANTIBIOTIC?
The generic name for TRIPLE ANTIBIOTIC is Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl. There are no other listed brand versions of Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl.
What is the NDC code for TRIPLE ANTIBIOTIC 500 [USP'U]/g?
The NDC (National Drug Code) for TRIPLE ANTIBIOTIC 500 [USP'U]/g is 21922-101, listed by Encube Ethicals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)