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

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)

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic


Medication Information

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)

Uses

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

  • cuts
  • scrapes
  • burns
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

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

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
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

Uses (USES)

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

  • cuts
  • scrapes
  • burns
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)

Purpose (PURPOSE)

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

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

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
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)