Neosporin ®

Neosporin ®
SPL v5
SPL
SPL Set ID 6752f0a0-2432-4d8b-8198-74ae96a68963
Route
TOPICAL
Published
Effective Date 2024-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Neomycin (3.5 mg) Polymyxin B (10000 [iU]) Pramoxine (10 mg)
Inactive Ingredients
Water Mineral Oil Petrolatum Propylene Glycol Methylparaben Sulfuric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-08

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort 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
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)
  • Product may settle
Inactive Ingredients

Water, Emulsifying Wax, Mineral Oil, Petrolatum, Propylene Glycol, Methylparaben, Sulfuric acid, Sodium Hydroxide

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 ®

for kids ages 2+

+ PAIN RELIEF

Maximum Strength



Pain Relief and



Infection Protection

Soothes Cuts, Scrapes,



and Burns

NO STING

CREAM

FIRST AID ANTIBIOTIC/PAIN RELEIVING CREAM

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 or discomfort 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
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)
  • Product may settle
Inactive Ingredients (Inactive ingredients)

Water, Emulsifying Wax, Mineral Oil, Petrolatum, Propylene Glycol, Methylparaben, Sulfuric acid, Sodium Hydroxide

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 ®

for kids ages 2+

+ PAIN RELIEF

Maximum Strength



Pain Relief and



Infection Protection

Soothes Cuts, Scrapes,



and Burns

NO STING

CREAM

FIRST AID ANTIBIOTIC/PAIN RELEIVING CREAM

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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