Sunmark™

Sunmark™
SPL v2
SPL
SPL Set ID c07d4042-c5f0-4abc-8d5f-76893eec1fc8
Route
TOPICAL
Published
Effective Date 2013-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (3.5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1995-12-14

Description

Drug Facts


Medication Information

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 reach of children. If swallowed get medical help or contact a Poison Control Center right away

Section 50570-1

Do not use if you are allergic to any of the ingredients

Section 55105-1
Active ingredients (in each gram) Purposes
Bacitracin 400 units First aid antibiotic
Neomycin 3.5 mg First aid antibiotic
Polymyxin B 5,000 units First aid antibiotic
Warnings

For external use only

Directions
  • unscrew cap and pull tab to remove foil seal
  • 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
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient

white petrolatum

When Using This Product
  • do not use in the eyes
  • do not apply over large areas of the body
Stop Use and Ask A Doctor If
  • you need to use for more 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
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel 28.4 G Tube Carton

sunmark

triple antibiotic ointment

polymyxin B sulfate • bacitracin zinc • neomycin sulfate

First Aid Antibiotic

ORIGINAL STRENGTH

NET WT 1 OZ (28.4 g)


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 reach of children. If swallowed get medical help or contact a Poison Control Center right away

Section 50570-1 (50570-1)

Do not use if you are allergic to any of the ingredients

Section 55105-1 (55105-1)
Active ingredients (in each gram) Purposes
Bacitracin 400 units First aid antibiotic
Neomycin 3.5 mg First aid antibiotic
Polymyxin B 5,000 units First aid antibiotic
Warnings

For external use only

Directions
  • unscrew cap and pull tab to remove foil seal
  • 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)
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient (Inactive ingredient)

white petrolatum

When Using This Product (When using this product)
  • do not use in the eyes
  • do not apply over large areas of the body
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use for more 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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

sunmark

triple antibiotic ointment

polymyxin B sulfate • bacitracin zinc • neomycin sulfate

First Aid Antibiotic

ORIGINAL STRENGTH

NET WT 1 OZ (28.4 g)


Advanced Ingredient Data


Raw Label Data

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