TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Triple Antibiotic Plus Pain Relief by

Drug Labeling and Warnings

Triple Antibiotic Plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (each gram contains)	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 or discomfort in minor:

• cuts
• scrapes
• burns

Warnings

For external use only.

Do not use

• in the eyes
• over large areas of the body
• if you are allergic to any of the ingredients.

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
• a 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 and dry thoroughly
• 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

• To open: unscrew cap, pull tab to remove foil seal
• store at 20° to 25°C (68° to 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

Questions?

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Label

First Aid Antibiotic
Pain Relieving Ointment

Maximum Strength
Triple Antibiotic
Ointment + Pain
Relief

Bacitracin Zinc ∙ Neomycin Sulfate
Polymyxin B Sulfate ∙ Pramoxine Hydrochloride

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 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: 51672-2027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin Zinc	500 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin Sulfate	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
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2027-1	1 in 1 CARTON	03/31/2012
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51672-2027-2	1 in 1 CARTON	03/31/2012
2		28.4 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	03/31/2012

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2027)