Neosporin Pain Itch Scar: Package Insert and Label Information

NEOSPORIN PAIN ITCH SCAR- bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride ointment
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
Bacitracin 500 units First aid antibiotic
Neomycin 3.5 mg First aid antibiotic
Polymyxin B 10,000 units First aid antibiotic
Pramoxine HCl 10 mg External analgesic

Uses

first aid to help prevent infection and for 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 Center 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)

Inactive ingredients

Petrolatum, Gossypium Herbaceum (Cotton) Seed Oil, Olea Europaea (Olive) Fruit Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Sodium Pyruvate

Questions?

call toll-free 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 + ITCH + SCAR

Maximum Strength:
Infection Protection,
Pain and Itch Relief

24-Hour Infection
Protection

Minimizes the
Appearance
of Scars

NO STING

OINTMENT

FIRST AID ANTIBIOTIC/PAIN RELIEVING OINTMENT
Bacitracin Zinc — Neomycin Sulfate — Polymyxin B Sulfate –
Pramoxine HCl

NET WT 1.0 OZ (28.3 g)

PRINCIPAL DISPLAY PANEL -- 28.3 g Tube Carton
(click image for full-size original)
NEOSPORIN PAIN ITCH SCAR
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0093
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [iU] in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [iU] in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
LEVANT COTTONSEED OIL
OLIVE OIL
COCOA BUTTER
.ALPHA.-TOCOPHEROL ACETATE
SODIUM PYRUVATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0093-1 1 TUBE in 1 CARTON contains a TUBE
1 28.3 g in 1 TUBE This package is contained within the CARTON (69968-0093-1)
2 NDC:69968-0093-2 1 TUBE in 1 CARTON contains a TUBE
2 14.2 g in 1 TUBE This package is contained within the CARTON (69968-0093-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 01/15/2016
Labeler — Johnson & Johnson Consumer Inc. (002347102)

Revised: 09/2021 Johnson & Johnson Consumer Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.