NEOSPORIN PAIN ITCH SCAR- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Neosporin Pain Itch Scar by

Drug Labeling and Warnings

Neosporin Pain Itch Scar by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

+ PAIN ● ITCH ● SCAR OINTMENT

NEOSPORIN® + PAIN ITCH SCAR
Bacitracin Zinc ● neomycin Sulfate ● Polymyxin B Sulfate ● Pramoxine HCl
FIRST AID ANTIBIOTIC/PAIN RELIEVING OINTMENT

NET WT 1.0 oz (28.3 g)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [iU]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Petrolatum (UNII: 4T6H12BN9U)
Levant Cottonseed Oil (UNII: N5CFT140R8)
Olive Oil (UNII: 6UYK2W1W1E)
Cocoa Butter (UNII: 512OYT1CRR)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Sodium Pyruvate (UNII: POD38AIF08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0093-1	1 in 1 CARTON	01/15/2016
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69968-0093-2	1 in 1 CARTON	01/15/2016
2		14.2 g in 1 TUBE; Type 0: Not a Combination Product

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)