Gopaldas (as CMO) - SOFSKIN TRIPLE ANTIBIOTIC OINTMENT + PAIN RELIEF (61040-134)

Manufacturer
GOPALDAS VISRAM AND COMPANY LIMITED
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:41:50

Label at a glance#

ProductSOFSKIN TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
Active ingredientPRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure9 sections

Indications and uses

First aid to help prevent infection and for the temporary relief of pain in minor: cuts scrapes burns

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (500 units)
Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)
Polymyxin B Sulfate (10,000 units)
Pramoxine Hydrochloride (10 mg)

PURPOSE

OTC - PURPOSE SECTION

First aid antibiotic
First aid antibiotic
First aid antibiotic
External analgesic

USES

INDICATIONS & USAGE SECTION

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

  • cuts
  • scrapes
  • burns

WARNINGS

WARNINGS SECTION

  • 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, or 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

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 (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • do not use if seal on the tube is damaged or is not visible
  • to open, unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat and humidity
  • see crimp of tube or carton for Lot Number and Expiry Date

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

WHITE PETROLATUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

UC-FRONTUC-FRONT

UC-BACKUC-BACK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN1
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD1
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61040-134-01SOFSKIN TRIPLE ANTIBIOTICPLUS PAIN RELIEF28.4 g in 1 TUBEOINTMENT28.41
61040-134-11SOFSKIN TRIPLE ANTIBIOTICPLUS PAIN RELIEF1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61040-134SOFSKIN TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [GOPALDAS VISRAM AND COMPANY LIMITED]12 package rows20241212_28ed6c7a-3744-2ab4-e063-6294a90a6237.zip

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
61040-13461040-134-01, 61040-134-11

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
28ed7671-0458-3dc5-e063-6394a90a10de28ed6c7a-3744-2ab4-e063-6294a90a62372024-12-10WarningsExact identifier
spl id: 28ed7671-0458-3dc5-e063-6394a90a10de
spl set id: 28ed6c7a-3744-2ab4-e063-6294a90a6237

Reported adverse events (FAERS/openFDA)#

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