TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment 
Salado Sales, Inc

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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Triple Antibiotic

Drug Facts

Active ingredients (in each gram)Purpose
Bacitracin zinc USP 400 unitsFirst aid antibiotic
Neomycin sulfate USP 3.5 mgFirst aid antibiotic
Polymyxin B sulfate USP 5,000 unitsFirst aid antibiotic

Uses

first aid to help prevent infection in minor:

Warnings

For external use only.

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • 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

Other information

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Questions?

Call 1-866-923-4914

Distributed by Salado Sales, Inc., Temple, Texas 76503-6115

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

TRIPLE ANTIBIOTIC
OINTMENT

Bacitracin Zinc USP • Neomycin Sulfate USP
• Polymyxin B Sulfate USP

FIRST AID ANTIBIOTIC OINTMENT

NET WEIGHT ½ OZ (14.2 g)

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
sucrose (UNII: C151H8M554)  
cottonseed oil (UNII: H3E878020N)  
olive oil (UNII: 6UYK2W1W1E)  
sodium pyruvate (UNII: POD38AIF08)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57243-120-011 in 1 CARTON10/27/2016
10.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B12/15/2015
Labeler - Salado Sales, Inc (009830555)

Revised: 12/2016
Document Id: 4a9f8454-d28e-49e3-b179-5fe244770ffb
Set id: 52e275d3-88c9-47f1-8dcf-68445c7be4a7
Version: 1
Effective Time: 20161205
 
Salado Sales, Inc