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  5. Label Information: Triple Antibiotic

FDA Label for Triple Antibiotic

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH GRAM)
    3. PURPOSES
    4. USES
    5. WARNINGS
    6. DO NOT USE:
    7. ASK A DOCTOR BEFORE USE:
    8. STOP USE AND ASK A DOCTOR IF:
    9. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. QUESTIONS OR COMMENTS? 1-800-456-7077
    14. PRINCIPAL DISPLAY PANEL – 0.5G POUCH LABEL
    15. PRINCIPAL DISPLAY PANEL – BOX LABEL

Triple Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Safetec Of America, 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.

Other



Drug Facts


Active Ingredient (In Each Gram)



Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

Polymyxin-B Sulfate 5000 units


Purposes



First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic


Uses



First aid to help prevent infection in minor cuts, scrapes and burns


Warnings



For external use only


Do Not Use:



  • in the eyes
  • internally
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask A Doctor Before Use:



  • in case of deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If:



  • the condition persists or gets worse
  • a rash or other allergic reaction develops

Keep This And All Drugs Out Of The Reach Of Children.



In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.


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 room temperature (do not freeze)
  • Do Not Use any Opened or Torn Packets

Inactive Ingredient



Petrolatum


Questions Or Comments? 1-800-456-7077



Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 • 800-456-7077
www.safetec.com


Principal Display Panel – 0.5G Pouch Label



Safetec

Triple Antibiotic Ointment™

0.5 g (1/57 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077


Principal Display Panel – Box Label



NDC 61010-5603-4

Safetec

First Aid

Triple Antibiotic Ointment™

First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder no. 53214

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com


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