Shopko Triple Antibiotic
FDA Label NDC 68169-0022

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tai Guk Pharm. Co., Ltd. for the product Shopko Triple Antibiotic (NDC 68169-0022). 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 (each gram contains)                                                                   Purpose

Bacitracin zinc 400 units ........................................................................................Antibiotic

Neomycin Sulfate equivalent to 3.5mg of Neomycin Base ........................................Antibiotic

Polymyxin-B Sulfate 5000 units ..............................................................................Antibiotic

Otc - Purpose

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and ask a doctor if

  • the condition persists or gets worse
  • 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

Indications & Usage

Directions

  • 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

Storage And Handling

Other information

  • store at 15o to 25oC (59o to 77oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Dosage & Administration

Distributed by

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Shopkotripleantibiotic)

Image Of Carton Label (Shopkotripleantibiotic)

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