TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b ointment 
Padagis Israel Pharmaceuticals Ltd

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.

----------

Triple Antibiotic Ointment Drug Facts

Active ingredients (in each gram)

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

Purpose

First aid antibiotic

Use

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. (1-800-222-1222)

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 20-25°C (68-77°F)

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Long Lasting Protection Against Infection

First Aid Antibiotic

#1 DOCTOR RECOMMENDED COMBINATION OF ACTIVE INGREDIENTS

Compare to Neosporin® active ingredients

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

First Aid Antibiotic

NET WT 0.5 OZ (14 g)

Padagis™

Triple Antibiotic Ointment Carton Image 1
Triple Antibiotic Ointment Carton Image 2
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin, polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-143
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
PETROLATUM (UNII: 4T6H12BN9U)  
COCOA BUTTER (UNII: 512OYT1CRR)  
COTTONSEED OIL (UNII: H3E878020N)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM PYRUVATE (UNII: POD38AIF08)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorWHITE (Translucent) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-143-011 in 1 CARTON05/20/2014
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:45802-143-031 in 1 CARTON05/20/2014
228 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:45802-143-70144 in 1 CARTON05/20/2014
3.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/20/2014
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 3/2022
Document Id: dcf538de-596c-4411-9eb5-c27f40c5644c
Set id: 28fff253-ddd4-4669-aa90-b4caf48c905f
Version: 6
Effective Time: 20220325
 
Padagis Israel Pharmaceuticals Ltd