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  5. Label Information: Triple Antibiotic Plus Pain Relief

FDA Label for Triple Antibiotic Plus Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH GRAM)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENT
    9. QUESTIONS OR COMMENTS?
    10. PRINCIPAL DISPLAY PANEL

Triple Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Bi-mart. 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 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate 10000 units

Pramoxine Hydrochloride 10 mg


Purposes



First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic


Uses



first aid to help prevent infection and for the temporary relief of pain 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 1 week
        • condition persists or gets worse
        • symptoms persist for more than 1 week, or clear up and occur again within a few day
        • 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 (1-800-222-1222) right away.


Directions



Adults and children 2 years of age and older

  • clean 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

    • Children under 2 years of age:ask a doctor


Other Information



  • do not use if seal on the tube is damaged or is not visible. 
  • to open, unscrew cap, pull tab to remove foil seal.
  • Store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat and humidity
  • see crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredient



White Petrolatum


Questions Or Comments?



Call 1-800-935-6737


Principal Display Panel



NDC 37835-904-01

Triple Antibiotic Ointment + Pain Relief

First Aid Antibiotic/Pain Relieving Ointment

Compare to the Active Ingredients in Neosporin ®+ Pain Relief *

*This product is not manufactured or distributed by Johnson & Johnson Corporation Products Company, Inc, owner of the registered trademark Neosporin ®+ Pain Relief .

Net. Wt. 1 oz (28.4 g)

Distributed by:

Bi-Mart

Eugene, OR 97402

Carton - triple antibiotic plus pain relief

Carton - triple antibiotic plus pain relief


* Please review the disclaimer below.