1. Home
  2. Labeler Index
  3. Winco Foods, Llc
  4. 67091-272
  5. Label Information: Winco Maximum Strength Triple Antibiotic

FDA Label for Winco Maximum Strength Triple Antibiotic

View Indications, Usage & Precautions

Table of Contents

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

Winco Maximum Strength Triple Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, 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.

Otc - Active Ingredient



Active ingredients                                                                                                       Purpose

Bacitracin zinc 500 units.............................................................................First aid antibiotic

Neomycin sulfate 3.5 mg............................................................................First aid antibiotic

Polymyxin B sulfate 10,000 units.................................................................First aid antibiotic

Pramoxine hydrochloride 10 mg..................................................................External analgesic


Otc - Purpose



Uses

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

  • cuts
  • scrapes
  • burns

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Stop Use



Stop use and ask a doctor if

  • you need to use longer than 1 week
  • the 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 right away


Indications & Usage



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: ask a doctor

Storage And Handling



Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients

liquid paraffin, white petrolatum


Otc - Questions



Questions? Or to report an adverse even call 800-824-1706 Monday - Friday 9am - 4pm MST


Dosage & Administration



DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

MADE IN KOREA


* Please review the disclaimer below.