Triple Antibiotic
FDA Label NDC 50607-5600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by B8 Sales, Inc. for the product Triple Antibiotic (NDC 50607-5600). 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 other, active ingredients (in each gram), purpose, uses, warnings, do not use, stop use and ask a doctor if, adults and children 2 years and over:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Triple Antibiotic Ointment™

First Aid to Help Prevent Infection In Minor Cuts, Scrapes, and Burns

25 Packets

Each Packet Net.Wt.0.9gm

Active Ingredients (In Each Gram)

Bacitradn Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg Neomycin base)

Polymyxin-B Sulfate 5000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do Not Use

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

Stop Use And Ask A Doctor If

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

    • Keep out reach of children. If swallowed, get

    medical help or contact a Poison Control Center right away.

Adults And Children 2 Years And Over:

  • 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 dally
  • may be covered with a sterile bandage

Children Under 2 Years:

  • consult a doctor

Other Information

  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

Inactive Ingredients

petrolatum

Triple Antibiotic Ointment™

Manufactured for:

B8 SALES

Cincinnati,0hio 4521S

888-826-6208

www.b8sales.com

PIO Put it on®

Principal Display Panel

Triple Antibiotic Ointment – Carton Label

PIO Put it on®

Triple Antibiotic Ointment™

First Aid to Help Prevent Infection In Minor Cuts, Scrapes, and Burns

25 Packets

Each Packet Net.Wt.0.9gm

Triple Antibiotic Ointment – Carton Label (Triple Antibiotic Ot 01)

Triple Antibiotic Ointment – Carton Label (Triple Antibiotic Ot 01)

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