TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Acme United Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 – packet

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

PRINCIPAL DISPLAY PANEL – bag
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin zinc - UNII:89Y4M234ES) bacitracin zinc400 [iU]  in 1 g
neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin sulfate3.5 mg  in 1 g
polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K) polymyxin b sulfate5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5603-026 in 1 BAG
1NDC:0924-5603-010.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/27/2012
Labeler - Acme United Corporation (001180207)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE

Revised: 1/2012
Document Id: 29d034b8-1c10-4319-894e-67abf6507cb8
Set id: fe15585f-147b-4e14-9ba3-7c5a1a9a7e74
Version: 1
Effective Time: 20120127
 
Acme United Corporation