Otc - Active Ingredient
Active ingredient Purpose
Bacitracin (500 Units in each gram).......First Aid Antibiotic
Bacitracin Ointment
FDA Label NDC 68001-477
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Bacitracin (NDC 68001-477). 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 otc - active ingredient, purpose, warnings:, dosage and administration:, stop use and ask a doctor if, do not use:, keep out of reach of children, indications and usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First aid to help prevent infection in:
Minor cuts
scrapes
burns
Warnings:
For external use only
Dosage And Administration:
- clean the affected area
- apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Stop Use And Ask A Doctor If
- the condition persists or gets worse, or if a rash or other allergic reaction develops.
Do Not Use:
- in the eyes or apply over large areas of body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
Keep Out Of Reach Of Children
if swallowed, get medical help or contact a Poison Control Center right away
Indications And Usage
Ask a doctor before use if you have:
- deep or puncture wounds
- animal bites
- serious burns
Other Information
- store at controlled room temperature
Inactive Ingredients
Hard Paraffin, Liquid Paraffin, White Soft Paraffin
Questions?
Contact- 1-800-707-4621
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