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

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
    • 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)
  • Product may settle
Inactive Ingredients

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

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
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 ®

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

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

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

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
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 ®

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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