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  5. Label Information: Neomycin And Polymyxin B Sulfates And Bacitracin Zinc

FDA Label for Neomycin And Polymyxin B Sulfates And Bacitracin Zinc

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH GRAM)
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR/PHARMACIST
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DOSAGE & ADMINISTRATION
    10. OTHER
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 OZ CONTAINER

Neomycin And Polymyxin B Sulfates And Bacitracin Zinc Product Label

The following document was submitted to the FDA by the labeler of this product H.j. Harkins Company, 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.

Active Ingredients (In Each Gram)



  •   Neomycin Sulfate (5 mg equivalent to 3.5 mg neomycin base)
  •   Polymyxin B Sulfate (equal to 5.000 polymyxin B units)
  •   Bacitracin Zinc (equal to 400 bacitracin units)

Purpose



Antibiotic
Antibiotic
Antibiotic


Indications & Usage



Uses

first aid to help prevent infection in
  • minor cuts
  • scopes
  • bums

Otc - Do Not Use



Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Otc - Ask Doctor/Pharmacist



Ask a doctor before use in case of deep or puncture wounds, animal bites or serous bums


Otc - When Using



When using this product do not use longer than 1 week unless directed by a doctor


Otc - Stop Use



Stop use and ask a doctor if

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

Keep Out Of Reach Of Children.



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


Dosage & Administration



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



Other information

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
  • store at room temperature
  • see crimp of tube for Lot No. and Exp, date

Inactive Ingredient



Inactive ingredient white petrolatum

Questions or comments? call toll free 1-800-645-9833


Package Label – Principal Display Panel – 1/2 Oz Container



Fougera®

NDC 52959-014

Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

Repacked by:

H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA

Label - label

Label - label




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