Sunmark®

Sunmark®
SPL v5
SPL
SPL Set ID 3948510f-10b9-454f-9da8-022559d460db
Route
TOPICAL
Published
Effective Date 2020-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Polymyxin B (10000 [USP'U])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1990-12-05

Description

Drug Facts

How Supplied

Product: 50090-3010 NDC: 50090-3010-0 28.4 g in a TUBE / 1 in a CARTON


Medication Information

How Supplied

Product: 50090-3010

NDC: 50090-3010-0 28.4 g in a TUBE / 1 in a CARTON

Description

Drug Facts

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children.

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

Section 55105-1
Active ingredients (in each gram) Purpose
Bacitracin zinc 500 units First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Warnings

For external use only

Directions
  • clean the affected area and dry thoroughly
  • 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
Do Not Use
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week
Questions?

Call 1-866-923-4914

Other Information
  • To Open: unscrew cap, pull tab to remove foil seal.
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient

white petrolatum

Ask A Doctor Before Use
  • on deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If
  • condition persists or gets worse
  • a rash or other allergic reaction develops
Bacitracin Zinc and Polymyxin B Sulfate

Structured Label Content

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Section 55105-1 (55105-1)
Active ingredients (in each gram) Purpose
Bacitracin zinc 500 units First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Warnings

For external use only

Directions
  • clean the affected area and dry thoroughly
  • 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
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week
Questions?

Call 1-866-923-4914

How Supplied (HOW SUPPLIED)

Product: 50090-3010

NDC: 50090-3010-0 28.4 g in a TUBE / 1 in a CARTON

Other Information (Other information)
  • To Open: unscrew cap, pull tab to remove foil seal.
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient (Inactive ingredient)

white petrolatum

Ask A Doctor Before Use (Ask a doctor before use)
  • on deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition persists or gets worse
  • a rash or other allergic reaction develops
Bacitracin Zinc and Polymyxin B Sulfate (Bacitracin zinc and Polymyxin B sulfate)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)