NEOSPORIN PLUS PAIN RELIEF- bacitracin, neomycin, polymyxin b, 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.

----------

NEOSPORIN®+PAIN RELIEF OINTMENT

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 temporarily 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 2years of age: ask a doctor

Other information

store at 20 ° to 25°C (68°to 77°F)

Inactive ingredient

white petrolatum

Questions?

Call Toll Free 800-223-0182 or Outside US, dial collect 215-273-8755

Dist. Johnson & Johnson Consumer Products Company
Division of Johnson & Johnson Consumer Companies, Inc.
Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

+PAIN RELIEF OINTMENT

NEOSPORIN®+PAIN
RELIEF
Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate-Pramoxine HCl
FIRST AID ANTIBIOTIC/PAIN RELIEVING OINTMENT

NET WT 1 oz (28.3 g)

Principal Display Panel - 28.3 g Tube Carton

NEOSPORIN PLUS PAIN RELIEF
bacitracin, neomycin, polymyxin b, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-4003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58232-4003-1	1 in 1 CARTON	12/01/2009	05/01/2018
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58232-4003-2	1 in 1 CARTON	12/01/2009	05/01/2018
2		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333B	12/01/2009	05/01/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2016

Document Id: ef68cd15-eea2-4852-bb34-50b90e37f697

Set id: 27db5da1-9616-4b11-bba9-d30f701d52ec

Version: 3

Effective Time: 20160421

Johnson & Johnson Consumer Inc.