FDA Label for Topcare Triple Antibiotic Plus Pain Relief

View Indications, Usage & Precautions

Topcare Triple Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates 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
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077


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 hydrochloride 10 mgExternal analgesic

Uses



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

  • cuts
  • scrapes
  • burns

Warnings



For external use only.


Do Not Use



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

Ask A Doctor Before Use If You Have



  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use And Ask A Doctor If



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


Directions



  • Adults and children 2 years of age and older:
    • 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
    • Children under 2 years of age: ask a doctor

Other Information



  • To open: unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredient



white petrolatum


Questions?



1-888-423-0139


Principal Display Panel - 28.4 G Tube Carton



TopCare®

MAXIMUM STRENGTH

Triple Antibiotic Ointment
+ Pain Relief

BACITRACIN ZINC, NEOMYCIN SULFATE
POLYMYXIN B SULFATE AND PRAMOXINE HCL

QUALITY
GUARANTEED

COMPARE TO
NEOSPORIN® + PAIN RELIEF
active ingredients*

NET WT 1 OZ (28.4 g)


* Please review the disclaimer below.