FDA Label for Sunmark Triple Antibiotic Plus Pain Relief

View Indications, Usage & Precautions

Sunmark Triple Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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.

Other



Drug Facts

Distributed by McKesson
One Post Street
San Francisco, CA 94104


Otc - Purpose



Active ingredients (in each gram)Purposes
Bacitracin 500 unitsFirst aid antibiotic
Neomycin 3.5 mgFirst aid antibiotic
Polymyxin B 10,000 unitsFirst aid antibiotic
Pramoxine HCl 10 mgTopical pain reliever

Uses



first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns

Warnings



For external use only


Otc - Do Not Use



Do not use if you are allergic to any of the ingredients


Otc - Ask Doctor



Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - When Using



When using this product

  • do not use in the eyes
  • do not apply over large areas of the body

Otc - Stop Use



Stop use and ask a doctor if

  • you need to use for more than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week or clear up and occur again within a few days
  • 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


Directions



  • unscrew cap and pull tab to remove foil seal
  • 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: ask a doctor

Other Information



  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredient



white petrolatum


Principal Display Panel - 28.4 G Tube Carton



sunmark

triple antibiotic ointment

plus pain reliever

polymyxin B sulfate • bacitracin zinc
neomycin sulfate • pramoxine hydrochloride

First Aid Antibiotic

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)


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