Neosporin ®

Neosporin ®
SPL v5
SPL
SPL Set ID 3caa7fd1-bd66-427e-a6c0-1b137b205089
Route
TOPICAL
Published
Effective Date 2024-10-28
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 2019-02-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

first aid to help prevent infection and for the temporary relief of pain 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 Centre right away.

Section 55105-1
Active ingredients (in each gram) 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 HCl (10 mg) External analgesic
Warnings

For external use only.

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
Do Not Use
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions?

call 800-223-0182 or outside the US 215-273-8755 (collect)

Other Information
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients

Petrolatum

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
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel 14.2 G Tube Carton

#1 DOCTOR



RECOMMENDED



BRAND



NEOSPORIN ®



+



BURN RELIEF



Maximum Strength



Pain Relief to



Soothe Minor Burns

24-Hour Infection



Protection

Triple Antibiotic



Formula

NO STING

OINTMENT



FIRST AID ANTIBIOTIC/ PAIN RELIEVING OINTMENT



Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate-



Pramoxine HCl



NET WT. 0.5 OZ (14.2 g)


Structured Label Content

Uses

first aid to help prevent infection and for the temporary relief of pain 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 Centre right away.

Section 55105-1 (55105-1)
Active ingredients (in each gram) 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 HCl (10 mg) External analgesic
Warnings

For external use only.

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
Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions?

call 800-223-0182 or outside the US 215-273-8755 (collect)

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

Petrolatum

Stop Use and Ask A Doctor If (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
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 14.2 G Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton)

#1 DOCTOR



RECOMMENDED



BRAND



NEOSPORIN ®



+



BURN RELIEF



Maximum Strength



Pain Relief to



Soothe Minor Burns

24-Hour Infection



Protection

Triple Antibiotic



Formula

NO STING

OINTMENT



FIRST AID ANTIBIOTIC/ PAIN RELIEVING OINTMENT



Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate-



Pramoxine HCl



NET WT. 0.5 OZ (14.2 g)


Advanced Ingredient Data


Raw Label Data

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