Active Ingredient
Bacitracin Zinc 500 Units
Bacitracin Zinc Ointment
FDA Label NDC 69396-163
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Bacitracin Zinc (NDC 69396-163). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, stop use and ask doctor if, directions, ask doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
Uses
First Aid to help prevent infection in
- minor cuts
- scrapes
- burns
Warnings
For External Use Only.
Do Not Use
- in eyes
- over large areas of the body
- if you are allergic to any of the ingredients
Stop Use And Ask Doctor If
- The condition persists or gets worse
- A rash or allergic reaction develops
Directions
- Clean the affected area and dry thoroughly.
- Apply a small amount of the 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
Ask Doctor Before Use If
you have deep or puncture wounds, aniimal bites or serious burns.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center Immediately.
Inactive Ingredients
Mineral oil, white petrolatum, paraffin
Questions
Call 1-888-296-9067
Fax: 1-888-878-3609
Online: www.trifecta-pharma.com
Reorder No. 1013SL
Storage Information
Store at room temperature 15° to 25°C (59° to 77°F).
Other Information
Distributed By:
Trifecta Pharmaceuticals USA®
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
* Please review the disclaimer below.
