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

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Drug Labeling and Warnings

sunmark by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purposes
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	Topical pain reliever

Uses

first aid to help prevent infection and for temporary 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

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not use in the eyes
• do not apply over large areas of the body

Stop use and ask a doctor if

• you need to use for more 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

• unscrew cap and pull tab to remove foil seal
• 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 controlled room temperature 15°-30°C (59°-86°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

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Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark™

triple antibiotic ointment

plus pain reliever

polymyxin B sulfate bacitracin zinc
neomycin sulfate pramoxine hydrochloride

First Aid Antibiotic

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-600-72	1 in 1 CARTON	02/13/2013
1		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 - Strategic Sourcing Services LLC (116956644)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(49348-600)