NEOSPORIN PLUS PAIN RELIEF FIRST AID ANTIBIOTIC/PAIN RELIEVING- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Neosporin Plus Pain Relief by

Drug Labeling and Warnings

Neosporin Plus Pain Relief 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
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 ingredients

Water, Emulsifying Wax, Mineral Oil, Petrolatum, Propylene Glycol, Methylparaben, Sulfuric acid, Sodium Hydroxide

Questions?

call 800-223-0182 or outside the US 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 RELIEF CREAM

• NEOSPORIN®: +PAIN ; RELIEF

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

NET WT 1 OZ (28.3 g)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)
Sulfuric acid (UNII: O40UQP6WCF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0055-2	1 in 1 CARTON	12/01/2009
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69968-0055-1	1 in 1 CARTON	12/01/2009
2		28.3 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 NOT FINAL	part348	12/01/2009

Labeler - Johnson & Johnson Consumer Inc. (002347102)