Triple Antibiotic Plus
FDA Label NDC 59450-823

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Triple Antibiotic Plus (NDC 59450-823). 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, uses, warnings, otc - do not use, otc - ask a doctor before use if you have, otc - when using this product, otc - stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

(in each gram)

Bacitracin zinc, USP 500 units

Neomycin Sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 10,000 units

Pramoxine hydrochloride, USP 10 mg

Otc - Purpose

First aid antibiotic/Pain reliever

Uses

First aid to help prevent infection and for temporary relief of pain or discomfort due to

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients

Otc - Do Not Use

  • in the eyes
  • over large areas of the body

Otc - Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious burns[/S][/S][/S]

Otc - When Using This Product

  • do not use longer than 1 week unless directed by a doctor

Otc - Stop Use And Ask A Doctor If

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

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

2  Dosage & Administration

Adults and children 2 years and older:

  • clean affected area
  • apply a small amount of this product (an 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

Other Information

  • Store at 59° -86°F (15° -30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient

White petrolatum

Otc - Questions Or Comments?

1-800-632-6900

Package Label.Principal Display Panel

Kroger®

QUALITY GUARANTEED

Compare to the active ingredients of NEOSPORIN® PLUS.

*See Back Panel.

maximum strength

TRIPLE ANTIBIOTIC OINTMENT

PLUS PAIN RELIEF

• Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

• First aid antibiotic plus topical pain reliever

NET WT 1 OZ (28 g)

08230611xx VC108014

  • 268d8196-figure-01 (268d8196 Figure 01)

    268d8196-figure-01 (268d8196 Figure 01)

    • 268d8196-figure-02 (268d8196 Figure 02)

    268d8196-figure-02 (268d8196 Figure 02)

    CARTON LABEL

* Please review the disclaimer below.