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

Warnings

For external use only.

Uses

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

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

Petrolatum

Description

Drug Facts

Questions?

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

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

Warnings

For external use only.

Uses

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

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

Petrolatum

Questions?

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

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