Bacitracin Zinc
FDA Label NDC 69396-008
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 69396-008). 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 drug facts, active ingredient, purpose, uses, warnings, directions, inactive ingredient:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Bacitracin Zinc 500 units
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 the eyes ●over large areas of the body ● if you are allergic to any of the ingredients ● longer than 1 week unless directed by a healthcare professional
Ask a healthcare professional before use in care of deep or puncture wounds, animal bites, or serious burns
Stop use and ask a healthcare professional if ● the condition persists or gets worse ● a rash or allergic reaction develops
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
Inactive Ingredient:
aloe vera gel, light mineral oil, white petrolatum
Other Information
● store between15° to 25°C ( 59° to 77°F) ● Lot No & Expiration Date: See box and tube crimp.
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