MedPath

Triple Antibiotic Plus Pain Relief

Triple Antibiotic Plus Pain Relief

Approved
Approval ID

bedc0643-c5a1-4199-88ea-dee86d8fda5b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Strategic Sourcing Services LLC

DUNS: 116956644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62011-0099
Application NumberM004
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (5)

PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
BACITRACIN ZINCActive
Quantity: 500 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIB
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
PRAMOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 g
Code: 88AYB867L5
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/27/2019

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Health Mart ®

FIRST AID

Triple Antibiotic Ointment
plus pain relief

• bacitracin zinc • neomycin sulfate • polymyxin B sulfate • pramoxine hydrochloride

Antibiotic Ointment

NET WT 1 oz (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/27/2019

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/27/2019

Distributed by McKesson
One Post Street, San Francisco, CA 94104

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/27/2019

Active ingredients (in each gram)

Purpose

Bacitracin zinc USP 500 units

First aid antibiotic

Neomycin sulfate USP 3.5 mg

First aid antibiotic

Polymyxin B sulfate USP 10,000 units

First aid antibiotic

Pramoxine HCl USP 10 mg

External analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 11/27/2019

Warnings

For external use only.

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • 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

**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/27/2019

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 SECTION

LOINC: 44425-7Updated: 11/27/2019

Other information

  • To open: unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/27/2019

Inactive ingredient

white petrolatum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/27/2019

Questions?

Call1-866-923-4914

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.