Triple Antibiotic Ointment

Manufacturer
Galentic Pharma (India) Private Limited
Effective date
2023-02-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:38:22

Label at a glance#

ProductTriple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure8 sections

Indications and uses

first aid to help prevent infection in minor: cuts scrapes burns

Dosage and administration

clean the affected areas apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily may be covered with a sterile bandage

Storage and handling

store at controlled room temperature 15°-30° C (59°-86° F)

Label contents#

Full prescribing information#

• ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each gram)  Purpose
Bacitracin Zinc 400 UnitsFirst Aid Antibiotic
Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)First Aid Antibiotic
Polymyxin B Sulfate 5000 UnitsFirst Aid Antibiotic

• USES

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

• WARNINGS

WARNINGS SECTION

For external use only

• DO NOT USE

OTC - DO NOT USE SECTION

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

• ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • Animal bites
  • Serious burns
  • Deep or puncture wounds

• STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • You need to use longer than 1 week
  • Condition persists or gets worse
  • Rash or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• KEEP OUT OF REACH OF CHILDREN.

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

• DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • clean the affected areas
  • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

• OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 15°-30° C (59°-86° F)

• INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

White Petrolatum

SPL UNCLASSIFIED SECTION

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Galentic

Triple Antibiotic
Ointment

FIRST AID ANTIBIOTIC

Helps Prevent Infection
in Minor Cuts, Scrapes and Burns

Bacitracin zinc, Neomycin Sulfate, Polymyxin-B Sulfate

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50382-02350382-023-11, 50382-023-12, 50382-023-13, 50382-023-04, 50382-023-21, 50382-023-05, 50382-023-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
f3b1d701-169b-b3a2-e053-2a95a90ae9f506dbbb55-9464-4c50-9fb1-cc1c4496c60a2023-02-02WarningsExact identifier
spl id: f3b1d701-169b-b3a2-e053-2a95a90ae9f5
spl set id: 06dbbb55-9464-4c50-9fb1-cc1c4496c60a

Reported adverse events (FAERS/openFDA)#

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