Triple Antibiotic Plus Pain Relief (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride) Ointment [Taro Pharmaceuticals U.s.a., Inc.] -

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]
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NDC	51672-2027-1, 51672-2027-2
Set ID	4545c043-8e8e-4288-b4d8-e6ec9d72f979
Category	HUMAN OTC DRUG LABEL
Packager	Taro Pharmaceuticals U.S.A., Inc.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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