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  5. Label Information: Bacitracin

FDA Label for Bacitracin

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. PURPOSE:
    3. WARNINGS:
    4. DOSAGE AND ADMINISTRATION
    5. INDICATIONS AND USAGE
    6. STOP USE AND ASK A DOCTOR IF:
    7. DO NOT USE IF:
    8. KEEP OUT OF REACH OF CHILDREN
    9. ASK A DOCTOR BEFORE USE:
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Bacitracin Product Label

The following document was submitted to the FDA by the labeler of this product Galentic Pharma (india) Priva Te 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.

Otc - Active Ingredient



Active ingredient               Purpose
Bacitracin 500 Units                Antibiotic


Purpose:



First aid to help prevent infection.


Warnings:



For external use only


Dosage And Administration



Directions:

  • clean the affected areas
  • apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Indications And Usage



First aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

Stop Use And Ask A Doctor If:



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

Do Not Use If:



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

Keep Out Of Reach Of Children



if swallowed, get medical help or contact a Poison Control Center right away


Ask A Doctor Before Use:



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


Other Information



  • store at controlled room temperature 15°-30° C (59°-86° F)

Inactive Ingredients



Light Mineral Oil, White Petrolatum


Principal Display Panel



Bacitracin Ointment:

Gal Bacitracin.jpg


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