gopaldas (as cmo) - sofskin triple antibiotic ointment + pain relief (61040-134)

gopaldas (as cmo) - sofskin triple antibiotic ointment + pain relief (61040-134)
SPL v1
SPL
SPL Set ID 28ed6c7a-3744-2ab4-e063-6294a90a6237
Route
topical
Published
Effective Date 2024-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pramoxine (10 mg) bacitracin (500 [USP'U]) neomycin (5 mg) polymyxin b (10000 [USP'U])
Inactive Ingredients
white petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-15

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic

Description

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


Medication Information

Warnings
  • 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

Uses

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

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Directions
  • 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
  • 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
Description

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4

Active Ingredients

Bacitracin Zinc (500 units)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate (10,000 units)

Pramoxine Hydrochloride (10 mg)

Inactive Ingredient

WHITE PETROLATUM


Structured Label Content

Warnings (WARNINGS)
  • 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

Uses (USES)

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

  • cuts
  • scrapes
  • burns
Purpose (PURPOSE)

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Directions (DIRECTIONS)
  • 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 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
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4 (51945-4)

Active Ingredients (ACTIVE INGREDIENTS)

Bacitracin Zinc (500 units)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate (10,000 units)

Pramoxine Hydrochloride (10 mg)

Inactive Ingredient (INACTIVE INGREDIENT)

WHITE PETROLATUM


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)