Otc - Active Ingredient
Bacitracin Zinc 500 units
Advanced First Aid Bacitracin
FDA Label NDC 67060-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Advanced First Aid Bacitracin (NDC 67060-400). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
first aid antibiotic
Indications & Usage
Uses:
First aid to help prevent infection in: • minor cuts • scrapes • burns
Warnings
Warnings:
• for external use only
Otc - Do Not Use
Do not use :
• in the eyes
• if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock
• over large areas of the body
• longer than 1 week unless directed by a doctor
Otc - Stop Use
Stop use and ask a doctor if:
• before use in case of deep puncture wounds, animal bites or serious burns
• if the condition persists or gets worse
• if a rash or other allergic reaction develops
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center right away.
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
Other Safety Information
Other Information:
• Tamper Evident. Do not use if packet is torn, cut or opened.
• Avoid excessive heat and humidity
• Store at a controlled room temperature 15° to 30°C (59° to 86°F)
Inactive Ingredient
Inactive Ingredients:
white petrolatum
Package Label.Principal Display Panel
Adv Bacitracin Jar (Bacitracinadvjar12 16)
Adv Bacitracin Tube (Bacitracinadvtube12 16)
Advbacitracinpacket (Bacitracinadvpacket12 16)
Advbacitracincarton (Bacitracinadvcarton12 16)
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