Winco Maximum Strength Triple Antibiotic Ointment
FDA Label NDC 67091-272

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Maximum Strength Triple Antibiotic (NDC 67091-272). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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