Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving: Package Insert and Label Information

NEOSPORIN PLUS PAIN RELIEF FIRST AID ANTIBIOTIC/PAIN RELIEVING- neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride cream
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

Uses

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

  • cuts
  • scrapes
  • burns

Warnings

For external use only.

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Centre right away.

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

Questions?

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

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL — 28.3 g Tube Carton

#1
DOCTOR
RECOMMENDED
BRAND
NEOSPORIN ®
+
PAIN RELIEF

Maximum Strength Pain Relief

Soothing Infection
Protection

Fast–Absorbing
Cream

NO STING

CREAM

FIRST AID ANTIBIOTIC/PAIN RELIEVING CREAM
Neomycin Sulfate-Polymyxin B Sulfate-Pramoxine HCl

NET WT. 1 OZ (28.3 g)

PRINCIPAL DISPLAY PANEL -- 28.3 g Tube Carton
(click image for full-size original)
NEOSPORIN PLUS PAIN RELIEF FIRST AID ANTIBIOTIC/PAIN RELIEVING
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0055
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP’U] in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
MINERAL OIL
PROPYLENE GLYCOL
WATER
PETROLATUM
SODIUM HYDROXIDE
SULFURIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0055-2 1 TUBE in 1 CARTON contains a TUBE
1 14.2 g in 1 TUBE This package is contained within the CARTON (69968-0055-2)
2 NDC:69968-0055-1 1 TUBE in 1 CARTON contains a TUBE
2 28.3 g in 1 TUBE This package is contained within the CARTON (69968-0055-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/01/2009
Labeler — Johnson & Johnson Consumer Inc. (002347102)

Revised: 09/2021 Johnson & Johnson Consumer Inc.

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