Circle K ®

Circle K ®
SPL v9
SPL
SPL Set ID 5fdb1312-8f5f-47d0-b762-11232df827fe
Route
TOPICAL
Published
Effective Date 2021-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Polymyxin B (5000 [iU]) Neomycin (3.5 mg)
Inactive Ingredients
Petrolatum Sodium Pyruvate Cottonseed Oil Cocoa Butter Olive Oil Alpha-tocopherol Acetate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-10-10 Until 2024-06-29

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

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 50569-3

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Section 55105-1
Active ingredients (in each gram) Purpose
Bacitracin Zinc 400 units First aid antibiotic
Neomycin Sulfate 5 mg (3.5 mg of Neomycin base) First aid antibiotic
Polymyxin-B Sulfate 5000 units First aid antibiotic
Warnings

For external use only.

Directions
  • 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
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 unless directed by a doctor
Questions?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Other Information
  • store at 20°C to 25°C (68°F to 77°F)
  • do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening
Inactive Ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Pdp/package Ndc 66715 5505

CIRCLE K™

triple antibiotic ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate First Aid Antibiotic Ointment

net wt 0.5 oz (14.2 g)

Stop Use and Ask A Doctor If
  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Principal Display Panel 14.2 G Tube Carton

24 HOUR

Infection Protection

Help Prevent Infection in

Minor Cuts, Scrapes and Burns

CIRCLE K ®

Compare to the Active

Ingredients in Neosporin ®*

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate

First Aid Antibiotic Ointment

NET WT 0.5 oz (14.2 g)


Structured Label Content

Use

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 50569-3 (50569-3)

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Section 55105-1 (55105-1)
Active ingredients (in each gram) Purpose
Bacitracin Zinc 400 units First aid antibiotic
Neomycin Sulfate 5 mg (3.5 mg of Neomycin base) First aid antibiotic
Polymyxin-B Sulfate 5000 units First aid antibiotic
Warnings

For external use only.

Directions
  • 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
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 unless directed by a doctor
Questions?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Other Information (Other information)
  • store at 20°C to 25°C (68°F to 77°F)
  • do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening
Inactive Ingredients (Inactive ingredients)

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Pdp/package Ndc 66715 5505 (PDP/Package - NDC 66715-5505)

CIRCLE K™

triple antibiotic ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate First Aid Antibiotic Ointment

net wt 0.5 oz (14.2 g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Principal Display Panel 14.2 G Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton)

24 HOUR

Infection Protection

Help Prevent Infection in

Minor Cuts, Scrapes and Burns

CIRCLE K ®

Compare to the Active

Ingredients in Neosporin ®*

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate

First Aid Antibiotic Ointment

NET WT 0.5 oz (14.2 g)


Advanced Ingredient Data


Raw Label Data

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