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Triple Antibiotic

Triple Antibiotic Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate)

Approved
Approval ID

c1c9bb83-4f79-4996-8019-9ee382bbf8c7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Rite Aid Corporation

DUNS: 014578892

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, Pramoxine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11822-2700
Application NumberM004
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate, Pramoxine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (5)

BACITRACIN ZINCActive
Quantity: 500 [iU] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
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
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/9/2025

Package label

![Bacitracin Zinc, USP 500 units, Neomycin 3.5 mg, Polymyxin B Sulfate, USP 10,000 units Pramoxine Hydrochloride, USP 10 mg](/dailymed/image.cfm?name=triple-antibiotic-with-pramoxine-ointment-ene- deli-1.jpg&id=897046)

RITE AID Maximum Strength Triple Antibiotic Ointment and Pain relief

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/9/2025

Uses

First aid to help prevent infection and for the temporary relief of pain in minor

  • cuts
  • scrapes
  • burns

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/9/2025

Other information

  • Store at 15º-30ºC (59º-86ºF)
  • Before using any medication, read all label directions. Keep carton, it contains important information.****

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/9/2025

Active ingredients (in each gram)

Bacitracin Zinc USP, 500 units

Neomycin 3.5 mg

Polymyxin B sulfate USP, 10,000 units

Pramoxine hydrochloride USP, 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/9/2025

Purpose

First aid antibiotic

Pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 9/9/2025

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 for longer than one week
  • condition persists or gets worse
  • rash or other allergic reaction develops
  • symptoms persist for more than one week, or clear up and occur again with a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/9/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/9/2025

Inactive ingredient

white petrolatum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/9/2025

Questions or comments?

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