Neosporin Plus Pain Relief (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride) Ointment [Johnson & Johnson Consumer Inc.] -

NEOSPORIN PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [JOHNSON & JOHNSON CONSUMER INC.]
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NDC	69968-0057-1, 69968-0057-2
Set ID	32302dcd-f3f1-408b-ae5f-e7d8b666f68f
Category	HUMAN OTC DRUG LABEL
Packager	Johnson & Johnson Consumer Inc.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin Zinc (500 units)	First aid antibiotic
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 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)
Inactive ingredient

Petrolatum
Questions?

call 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

#1
DOCTOR
RECOMMENDED
BRAND

NEOSPORIN ®
+
PAIN RELIEF

Maximum Strength
Pain Relief

24-Hour Infection
Protection

Soothes Cuts, Scrapes
and Burns

NO STING

OINTMENT

FIRST AID ANTIBIOTIC/PAIN RELIEVING OINTMENT

Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate-
Pramoxine HCl

NET WT 1 oz (28.3 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0057
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U] 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 [USP'U] 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
Packaging
1	NDC:69968-0057-2	1 in 1 CARTON	12/01/2009
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:69968-0057-1	1 in 1 CARTON	12/01/2009
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

Labeler - Johnson & Johnson Consumer Inc. (002347102)

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Medic

NEOSPORIN PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [JOHNSON & JOHNSON CONSUMER INC.]

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