TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment 
Preferred Pharmaceuticals, 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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Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate Ointment

ACTIVE INGREDIENTS

(in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

PURPOSE

First aid antibiotic

USES

Helps prevent infection in

WARNINGS

For external  use only

Allergy alert:

DO NOT USE

ASK A DOCTOR BEFORE USE IF YOU HAVE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN.

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

DIRECTIONS

Other Information

  • Store at controlled room temperature 59º - 86ºF (15º - 30ºC).
  • Protect from freezing.

INACTIVE INGREDIENT

White petrolatum

HOW SUPPLIED

Triple Antibiotic Ointment comes in 28gr tubes

NDC - 68788-9811-2

QUESTIONS?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Relabeled By Preferred Pharmaceuticals, Inc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment label
TRIPLE ANTIBIOTIC 
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9811(NDC:0472-0179)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) 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:68788-9811-228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/25/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9811)

Revised: 4/2012
Document Id: 149065ec-0c18-43e7-89de-6540bf48207b
Set id: 149065ec-0c18-43e7-89de-6540bf48207b
Version: 1
Effective Time: 20120425
 
Preferred Pharmaceuticals, Inc