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. , 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 (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 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

White Petrolatum

Questions or Comments?

1-800-456-7077

PRINCIPAL DISPLAY PANEL – pouch

Safetec

Triple Antibiotic
Ointment

0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

PRINCIPAL DISPLAY PANEL – 144 count box

NDC: 61010-5600-2

Safetec

First Aid
Triple Antibiotic Ointment

First Aid to Help Prevent
Infection in Minor Cuts,
Scrapes, and Burns

Reorder no. 53210
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969
Online: www.safetec.com

Principal Display Panel – 10 Packet Box Label

Safetec®

First Aid
Triple Antibiotic
Ointment

Helps prevent infection in minor
cuts, scrapes, and burns

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 53208

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5600
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-5600-1	0.9 g in 1 POUCH; Type 0: Not a Combination Product	08/08/2011
2	NDC: 61010-5600-2	144 in 1 BOX	08/08/2011
2		0.9 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 61010-5600-3	25 in 1 BOX	08/08/2011
3		0.9 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 61010-5600-4	10 in 1 BOX	04/01/2020
4		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	08/08/2011

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5600)