Genuine Triple Antibiotic

Manufacturer
GFA Production (Xiamen) Co., Ltd.
Effective date
2024-10-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:53:10

Label at a glance#

ProductGenuine Triple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure7 sections

Indications and uses

To help prevent infections in minor cuts, scrapes or burns.

Dosage and administration

Clean affected area, apply 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.

Label contents#

Full prescribing information#

Each Gram Contains:

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5mg Neomycin base)

Polymyxin B Sulfate 5000 units

Purpose:

OTC - PURPOSE SECTION

Uses:

INDICATIONS & USAGE SECTION

To help prevent infections in minor cuts, scrapes or burns.

Warnings:

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

in eyes, over large areas of the body, if allergic to any of the ingredients, or for more than one week unless directed by a physician.

Stop use and consult a doctor:

OTC - STOP USE SECTION

if the condition persists or gets worse, a rash or other allergic reaction develops.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Clean affected area, apply 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.

Other information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Vaseline 96.41 %

Mineral oil 2%

Purified water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-003GENUINE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) CREAM [GFA PRODUCTION (XIAMEN) CO., LTD.]7Unmatched20241010_901c105e-71b1-4268-bef6-eb310d4a734c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50814-00350814-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
24068fcf-35cb-b705-e063-6394a90a4e7d901c105e-71b1-4268-bef6-eb310d4a734c2024-10-09WarningsExact identifier
spl id: 24068fcf-35cb-b705-e063-6394a90a4e7d
spl set id: 901c105e-71b1-4268-bef6-eb310d4a734c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.