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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. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. PRINCIPAL DISPLAY PANEL
    12. PURPOSE
    13. INACTIVE INGREDIENTS

Triple Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, 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)



Bacitracin Zinc 500 unitsNeomycin 3.5mgPolymyxin B Sulfate 10,000 unitsPramoxine HCl 10mg

Otc - Purpose



Active ingredients
(each gram contains)		Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine HCI 10 mgExternal analgesic

Uses



First aid to help prevent infection and provide temporary relief of pain or discomfort 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



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
  • condition persists for more than 1 week, or clear up and occur again within a few days
  • 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.


Directions



  • adults and children 2 years of age and older:
    • 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
    • children under 2 years of age: consult a physician

Other Information



Store at 20°-25°C (68°-77°F)

Principal Display Panel



Triple Antibiotic Ointment + Pain Relief
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Ointment

Maximum Strength

image of carton label - tripleplus.carton

image of carton label - tripleplus.carton

NET WT 1 oz (28.3 g)



Purpose



First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic


Inactive Ingredients



white petrolatum


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