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

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

Polymyxin-B Sulfate 5000 units

Purposes

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use:

• in the eyes
• internally
• over large areas of the body
• if you are allergic to any of the ingredients
• longer than 1 week unless directed by a doctor

Ask a doctor before use:

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

Stop use and ask a doctor if:

• the condition persists or gets worse
• a rash or other allergic reaction develops

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

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

Other Information

• Store at room temperature (do not freeze)
• Do Not Use any Opened or Torn Packets

Inactive Ingredient

Petrolatum

Questions or Comments? 1-800-456-7077

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label

Safetec

Triple Antibiotic Ointment™

0.5 g (1/57 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

PRINCIPAL DISPLAY PANEL – Box Label

NDC: 61010-5603-4

Safetec

First Aid

Triple Antibiotic Ointment™

First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder no. 53214

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5603
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: 61010-5603-4	144 in 1 BOX	03/30/2007
1	NDC: 61010-5603-2	0.5 g in 1 POUCH; 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	03/30/2007

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5603)