FDA Label for Bacitracin Zinc

View Indications, Usage & Precautions

Bacitracin Zinc Product Label

The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals 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.

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Drug Facts

Distributed by: Stratus Pharmaceuticals Inc.
12379 SW 130th Street
Miami, Florida 33186


Active Ingredient (In Each Gram)



Bacitracin Zinc, USP 500 units


Purpose



First aid antibiotic


Uses



First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings



For external use only


Allergy Alert



  • do not use if allergic to any of the ingredients

Do Not Use



  • in the eyes
  • over large areas of the body

Ask A Doctor Before Use If You Have



  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product



  • do not use longer then one week unless directed by doctor

Stop Use And Ask A Doctor If



  • condition persists or gets worse
  • a rash or other allergic reaction develop

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.


Directions



  • Clean 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
  • May be covered with a sterile bandage

Other Information



  • Store at room temperature 59°F - 77°F (15°C - 25°C)
  • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Do not use if seal is punctured or is not visible
  • See crimp of tube and outside of carton for Lot Number and Expiration Date.
  • To open, reverse cap and puncture.

Inactive Ingredient



White petrolatum


Questions Or Comments?



Call toll-free 1-800-442-7882


Principal Display Panel - 28.35 G Tube Box



STRATUSCARE
NDC 58980-011-10

Bacitracin Zinc Ointment USP

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 g)

Distributed by:
STRATUS
PHARMACEUTICALS INC


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