VHB (as PLD) - SOFSKIN TRIPLE ANTIBIOTIC OINTMENT + PAIN RELIEF (76436-403)

Manufacturer
Viny Health and Beauty Products Inc
Effective date
2024-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:59:01

Label at a glance#

ProductSOFSKIN TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
Active ingredientPOLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, NEOMYCIN 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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76436-403SOFSKIN TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [VINY HEALTH AND BEAUTY PRODUCTS INC]2Unmatched20240716_1d4dac91-a044-77e7-e063-6294a90ab497.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
76436-40376436-403-01, 76436-403-11

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
47d50c97-df5f-6ebb-e063-6294a90ae7021d4dac91-a044-77e7-e063-6294a90ab4972026-01-07WarningsExact identifier
spl set id: 1d4dac91-a044-77e7-e063-6294a90ab497

Reported adverse events (FAERS/openFDA)#

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