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

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

Principal Display Panel – 10 Packet Box Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M004	08/08/2011

Labeler - Safetec of America, Inc. (874965262)

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

61010-5600, Triple Antibiotic Ointment