FDA Label for Bacitracin Zinc And Polymyxin B Sulfate
View Indications, Usage & Precautions
Bacitracin Zinc And Polymyxin B Sulfate Product Label
The following document was submitted to the FDA by the labeler of this product H.j. Harkins Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Gram)
Bacitracin Zinc (equal to 500 bacitracin units)
Polymyxin B Sulfate (equal to 10,000 polymyxin B units)
Purpose
Antibiotic
Antibiotic
Indications & Usage
Uses first aid to help prevent infection in
- minor cuts
- scrapes
- burn
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 bums
Otc - When Using
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
- do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature
- see crimp of tube for Lot No. and Exp. date
Inactive Ingredient
Inactive ingredient white petrolatum
Questions or comments ? call toll free 1-800-645-9833
Package Label – Principal Display Panel – 1/2 Oz Container
Fougera®
NDC 0168-0021-35
Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)
Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444
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