Active ingredients (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10.0 mg	Topical analgesic

USES

first aid to help prevent infection and provide 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
in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

the 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
     • 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: consult a doctor

OTHER INFORMATION

store at room temperature

INACTIVE INGREDIENT

light mineral oil, white petrolatum

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Plus Ointment
Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl
FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT
Net Wt. 1 oz
(28.4 g)

Carton

TRIPLE ANTIBIOTIC PLUS
polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0713-0622
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [USP'U] in 1 g
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin Zinc	500 [USP'U] in 1 g
Neomycin (UNII: I16QD7X297) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Light Mineral Oil (UNII: N6K5787QVP)
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0713-0622-31	28.4 g in 1 TUBE; Type 0: Not a Combination Product	02/28/1998

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M004	02/28/1998

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

Name	Address	ID/FEI	Business Operations
Establishment
Cosette Pharmaceuticals NC Laboratories, LLC		079419931	MANUFACTURE(0713-0622)

Triple Antibiotic Plus Ointment Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl