Drug Facts

Active Ingredients

(Each gram contains)

Bacitracin 400 units

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

Polymyxin-B Sulfate 5000 units

Purpose

First Aid Antibiotics

Uses:

First aid to help prevent infection in:

Minor cuts and scrapes
Minor burns

Warnings:

For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of the reach of children.

STOP USE AND ASK A DOCTOR IF:

Conditions worsen or clear up and then recur
The condition persists for more than 7 days
A rash or allergic reaction occurs

DO NOT USE:

In the eyes
Over large areas of the body
If you are allergic to any of the ingredients
Longer than 1 week unless directed by a doctor
On raw surfaces, blistered areas or serious burns
For deep lacerations or puncture wounds

WHEN USING THIS PRODUCT:

Avoid contact with the eyes or mucus membranes

Directions:

Tamper evident packaging, do not use if packet is opened or torn.

Adults and children:

Clean the affected area, apply a small amount of this product (equal to the surface area of a fingertip) 1 to 3 times daily

Other information:

Store at room temperature

Inactive ingredients:

Petrolatum

Questions about this product: Call 1-800-835-2263 with any questions about this product.

PRINCIPAL DISPLAY PANEL – packet

NDC 0924-5603-01

PhysiciansCARE

Triple Antibiotic
Ointment

0.5 g (1/57 oz.)

Acme United Corporation

Fairfield, CT 06824 800-835-2263

PRINCIPAL DISPLAY PANEL – 12 count box

PAC-KIT FIRST AID

UNIT
12-001

12 EACH

Triple Antibiotic
Ointment Packets

Contains 12 ea. First Aid Antibiotic ointment packets
(min. weight each, 0.5 gm) to help prevent infection in minor cuts,
scrapes and burns. See back panel for Drug Facts listing.

Distributed by Acme United Corporation Fairfield, CT 06824 · 800-835-2263

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-5603
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin zinc - UNII:89Y4M234ES)	bacitracin zinc	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 sulfate	5000 [iU] in 1 g

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

#	Item Code	Package Description
Packaging
1	NDC:0924-5603-04	12 in 1 BOX
1	NDC:0924-5603-01	0.5 g in 1 PACKET
2	NDC:0924-5603-05	25 in 1 BOX
2	NDC:0924-5603-01	0.5 g in 1 PACKET
3	NDC:0924-5603-06	60 in 1 BOX
3	NDC:0924-5603-01	0.5 g in 1 PACKET
4	NDC:0924-5603-07	144 in 1 BOX
4	NDC:0924-5603-01	0.5 g in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/21/2012

Labeler - Acme United Corporation (001180207)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(0924-5603)