SUNMARK TRIPLE ANTIBIOTIC- polymyxin b sulfate, bacitracin zinc, and neomycin sulfate ointment

sunmark by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purposes
Bacitracin 400 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 5,000 units	First aid antibiotic

Uses

first aid to help prevent infection 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

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark™

triple antibiotic ointment

polymyxin B sulfate bacitracin zinc neomycin sulfate

First Aid Antibiotic

ORIGINAL STRENGTH

NET WT 1 OZ (28.4 g)

INGREDIENTS AND APPEARANCE

SUNMARK   TRIPLE ANTIBIOTIC
polymyxin b sulfate, bacitracin zinc, and neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	400 [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	5000 [iU]  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-029-72	1 in 1 CARTON
1		28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	12/14/1995

Labeler - McKesson (177667227)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(49348-029)