shopko ®

shopko ®
SPL v3
SPL
SPL Set ID 5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa
Route
topical
Published
Effective Date 2014-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (500 [iU]) neomycin (3.5 mg) polymyxin b (10000 [iU]) pramoxine (10 mg)
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-03-31

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns
Directions
  • Adults and children 2 years of age and older:
    • 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
  • Children under 2 years of age: ask a doctor
Other Information
  • To open: unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Description

Drug Facts

Questions?

Call 1-866-923-4914

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 55105-1
Active ingredients (each gram contains) Purpose
Bacitracin zinc 500 units First aid antibiotic
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg External analgesic
Do Not Use
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Inactive Ingredient

white petrolatum

Stop Use and Ask A Doctor If
  • condition persists or gets worse
  • you need to use longer than 1 week
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • a 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

SHOPKO ®

NDC 37012-027-02

Maximum Strength

Triple Antibiotic Ointment+Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1OZ (28.4 g)


Structured Label Content

Warnings

For external use only.

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns
Directions
  • Adults and children 2 years of age and older:
    • 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
  • Children under 2 years of age: ask a doctor
Other Information (Other information)
  • To open: unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Questions?

Call 1-866-923-4914

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 55105-1 (55105-1)
Active ingredients (each gram contains) Purpose
Bacitracin zinc 500 units First aid antibiotic
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg External analgesic
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Inactive Ingredient (Inactive ingredient)

white petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition persists or gets worse
  • you need to use longer than 1 week
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • a 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)

SHOPKO ®

NDC 37012-027-02

Maximum Strength

Triple Antibiotic Ointment+Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1OZ (28.4 g)


Advanced Ingredient Data


Raw Label Data

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