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 Acme United Corporation, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate 3.5 mg

Polymyxin-B Sulfate 5000 units

Purpose

First Aid Antibiotics

Uses

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

Warnings

For external use only

Do not use

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

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 2 years and over:

• 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 cover with a sterile bandage

Children under 2 years:

• consult a doctor

Other information

• store at room temperature (do not freeze)
• do not use any opened or torn packets

Inactive ingredients

petrolatum

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 – bag

UNIT
12-001B

PAC-KIT FIRST AID

Triple Antibiotic
Ointment Packets

ANSI Z308.1-2003R
Contents: 6 Single Use Packets
0.5 gr. (1/57 fl. oz.)
See reverse for Drug Facts

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin zinc - UNII:89Y4M234ES)	bacitracin zinc	400 [iU]  in 1 g
neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297)	neomycin sulfate	3.5 mg  in 1 g
polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K)	polymyxin b sulfate	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: 0924-5603-02	6 in 1 BAG
1	NDC: 0924-5603-01	0.5 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/27/2012

Labeler - Acme United Corporation (001180207)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE