FDA Label for Triple Antibiotic

View Indications, Usage & Precautions

Triple Antibiotic 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 Ingredients (In Each Gram)



Bacitracin Zinc USP, 400 units

Neomycin 3.5 mg                                      

Polymyxin B Sulfate USP, 5,000 units


Purpose



First aid antibiotic


Uses



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 A Doctor If



■ you need to use longer than one week

■ condition persists 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 15°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.


Inactive Ingredient



white petrolatum


Questions Or Comments?



Call 1-833-285-4151


Principal Display Panel



Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-04

Net wt. 0.5 oz (14g)


Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-05

Net wt. 1 oz (28g)



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