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 Encube Ethicals Private Limited. 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 Ingredient(S)



(in each gram)
Bacitracin zinc, USP 500 units ............. First aid antibiotic


Purpose



First aid antibiotic 


Use(S)



First Aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Warnings



For External Use Only.


Do Not Use



  • if you are allergic to any of the ingredients
  • 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 

Stop Use And Ask Doctor If



  • you need to use longer than one week 
  • condition persist or gets worse 
  • rash or other allergic reaction develops 

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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 Information



  • store at 150C to 300C (590F to 860F)
  • before using any medication, read all label directions. Keep carton, it contains important information. 

Inactive Ingredients



white petrolatum


Questions Or Comments?



Call 1-833-285-4151


Mfg. Lic. No.: 362 


Manufactured by:
Encube Ethicals Pvt. Ltd.
Plot no. C-1, Madkaim
Industrial Estate, Madkaim,
Post: Mardol, Ponda,
Goa - 403 404, India.



Distributed by:
Encube Ethicals, Inc.
200 Meredith Drive,
Suite 202, Durham,
NC 27713, USA


Principal Display Panel



BACITRACIN ZINC OINTMENT, USP 

First aid antibiotic

NET WT. 0.5 OZ (14 g)

BACITRACIN ZINC OINTMENT, USP 

First aid antibiotic

NET WT. 1 OZ (28 g)


* Please review the disclaimer below.