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  5. Label Information: Budpak Triple Antibiotic Maximum Strength

FDA Label for Budpak Triple Antibiotic Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Budpak Triple Antibiotic Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Budpak 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.

Otc - Active Ingredient



Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U


Otc - Purpose



Purpose

First Aid Antibiotic


Indications & Usage



Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use on

  • on deep puncture wounds, animal bites, or serious burns

Otc - Stop Use



Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops


Otc - Keep Out Of Reach Of Children



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 and dry thoroughly
  • 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

  • Store at room temperature 20°C to 25°C (68°F to 77°C)
  • Lot No. Exp. Date: see crimp of tube

    • PRINCIPAL DISPLAY PANEL

    Budpak Triple Antibiotic

    First Aid Antibiotic Ointment

    NET WT 0.5 OZ (14 g)


Inactive Ingredient



Inactive Ingredients

Cocoa butter, Petrolatum, Cottonseed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.


Package Label.Principal Display Panel



image of package label - triple antibiotic

image of package label - triple antibiotic


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