FDA.reportPublic FDA data

PENTREXCILINA TRIPLE ANTIBIOTIC

Manufacturer
HEALTH LIFE
Effective date
2019-04-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:28:32

Label at a glance#

ProductPENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

FIRST AID TO HELP PREVENT INFECTION IN MINOR CUTS SCRAPES BURNS

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (IN EACH GRAM)

OTC - ACTIVE INGREDIENT SECTION

BACITRACIN ZINC  500 UNITS

NEOMYCIN SULFATE  5 MG  (EQUIVALENT TO 3.5 MG NEOMYCIN)

POLYMYXIN B SULFATE  5000 UNITS

PRAMOXINE HYCHLORIDE  10 MG

PURPOSE

OTC - PURPOSE SECTION

FIRST AID ANTIBIOTIC

PAIN RELIEVER

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

  • IN THE EYES
  • IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS
  • OVER LARGE AREAS OF THE BODY
  • LONGER THAN 1 WEEK UNLESS DIRECTED BY A DOCTOR

ASK A DOCTOR BEFORE USE IN CASE OF

  • DEEP OR PUNCTURE WOUNDS
  • ANIMAL BITES
  • OR SERIOUS BURNS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WHITE PETROLATUM

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • STORE AT 15° - 30°C (59°F - 86°F)
  • AVOID EXCESSIVE HEAT AND HUMIDITY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-LBL_Pentrexcilina Triple Antibiotic Plus Relief 0.5 oz0-LBL_Pentrexcilina Triple Antibiotic Plus Relief 0.5 oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-616-612024-06-13C16284748780-1ba0f9c33-57e7-a910-e053-dadaa90a0b85e32c338f-b046-46f9-a5d6-0b3f532f15d2
69517-616-612021-01-29C16284748780-1ba0f9c33-57e7-a910-e053-dadaa90a0b85e32c338f-b046-46f9-a5d6-0b3f532f15d2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-61669517-616-01, 69517-616-61

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
PETROLATUM4T6H12BN9UIACT

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
085b53ab-db64-b15b-e063-6394a90a51e7e32c338f-b046-46f9-a5d6-0b3f532f15d22024-06-13WarningsExact identifier
spl set id: e32c338f-b046-46f9-a5d6-0b3f532f15d2

Reported adverse events (FAERS/openFDA)#

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