Active Ingredient
Bacitracin Zinc 500 Units per gram
Major Bacitracin Ointment
FDA Label NDC 0904-7023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Major Bacitracin (NDC 0904-7023). 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, ask doctor before use, stop use and ask doctor if, directions, 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, due to the possiblity of anaphylactic shock
- longer than 1 week unless directed by a doctor
Ask Doctor Before Use
In care of deep puncture wounds, animal bites, or serious burns.
Stop Use And Ask Doctor If
- Before use in case of deep puncture wounds, animal bites or serious burns
- The condition persists or gets worse
- A rash or allergic reaction develops
Directions
- Clean the affected area
- 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
Inactive Ingredients
mineral oil, white petrolatum
Questions
Call 1-800-616-2471
Storage Information
Avoid excessive heat and humidity
Store at room temperature 15° to 30°C (59° to 86°F).
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other Information
Tamper evident. Do not use if packet is torn, cut or opened.
Distributed By:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152
Product of USA
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