Premier Value Triple Antibiotic Plus
FDA Label NDC 68169-0129

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 Premier Value Triple Antibiotic Plus (NDC 68169-0129). 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 - when using, otc - stop use, otc - keep out of reach of children, 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 (in each gram)                                                                           Purpose

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

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

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

Pramoxine hydrochloride 10 mg ............................................................................Pain reliever

Otc - Purpose

Uses

helps prevent infection and temporarily relieves pain due to minor cuts, scrapes, and burns.

Warnings

Warnings

For external use only

Allergy alert: do not use if allergies to any of the ingredients

Otc - Do Not Use

Do not use

  • in or near 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 - When Using

When using this product

do not use longer than 1 week

Otc - Stop Use

Stop use and ask a doctor if

  • condition lasts or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • rash or other allergic reaction occurs

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    Adults and children 2 years and older:

  • clean affected area
  • apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
  • may be covered with a sterile bandage
  • Children under 2 years: ask a doctor

Inactive Ingredient

Inactive ingredients

white petrolatum

Dosage & Administration

Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Corporate Blvd. Suite 101

Boca Raton, FL 33431

Package Label.Principal Display Panel

Image Of Carton Label (Pvtripleantibioticplus)

Image Of Carton Label (Pvtripleantibioticplus)

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