TRIPLE ANTIBIOTIC- bacitracin zinc and neomycin sulfate and 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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Triple Antibiotic Ointment

Active ingredients (in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 5 mg (equivalent to 3.5 mg Neomycin base)

Polymyxin B sulfate, USP 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor:

•
cuts
•
scrapes
•
burns

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

•
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 be covered with a sterile bandage

Other information

•
store at 15° to 30°C (59° to 86°F)
•
lot number and expiration date: See crimp of tube or box

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

mineral oil, white petrolatum

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/15 R9
8277485  0644

Relabeled By: Preferred Pharmaceuticals Inc.

28.4 g Tube NDC #68788-8995-2

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment
TRIPLE ANTIBIOTIC 
bacitracin zinc and neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8995(NDC:0603-0644)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  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 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-8995-228.4 g in 1 TUBE; Type 0: Not a Combination Product02/11/201611/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/11/201611/16/2017
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8995)

Revised: 11/2017
Document Id: 6989ccf8-6cb0-4d1a-8cd3-f3b8fd3a50ad
Set id: fbaa35f6-6ef6-4a9b-81c7-03f1a0151c32
Version: 2
Effective Time: 20171116
 
Preferred Pharmaceuticals Inc.