TRIPLE ANTIBIOTIC- bacitracin, neomycin, polymyxin b ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5 mg. Neomycin)

Polymyxin B Sulfate 5000 units

PURPOSE

first aid antibiotic

INDICATIONS & USAGE

Uses:

First aid to help prevent infection in: minor cuts burns scrapes

WARNINGS

Warnings:

For external use only

Do not use:

in the eyes if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock over large areas of the body longer than 1 week unless directed by a doctor

Stop use and ask a doctor:

before use in case of deep puncture wounds, animal bites or serious burns

if the condition persists or gets worse

if a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control

Center right away.

DOSAGE & ADMINISTRATION

Directions:

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.

INACTIVE INGREDIENT

Inactive Ingredients: petrolatum.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-360
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	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: 67060-360-39	25 in 1 CARTON	04/08/2015	10/17/2016
1		0.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67060-360-28	28 g in 1 TUBE; Type 0: Not a Combination Product	10/17/2016
3	NDC: 67060-360-47	144 in 1 CARTON	10/17/2016
3	NDC: 67060-360-09	0.9 g in 1 PACKET; 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	04/08/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-360)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-360)