Active Ingredients (In Each Gram)
Bacitracin Zinc (equal to 500 bacitracin units)
Bacitracin Zinc
FDA Label NDC 52959-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Bacitracin Zinc (NDC 52959-113). 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 ingredients (in each gram), purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
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 over large areas of the body if you are allergic to any of the ingredients
Otc - Ask Doctor
Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns
When using this product do not use longer than 1 week unless directed by a doctor
Otc - Stop Use
Stop use and ask a doctor 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
Other information store at room temperature
Inactive Ingredient
Inactive ingredient white petrolatum
Otc - Questions
E. FOUGERA and CO.a division of Nycomed US Inc.MELVILLE, NEW YORK 11747Repacked by:H.J. Harkins Company Inc.Nipomo, CA 93444
Package Label.Principal Display Panel
Label (Label1)
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