BUDPAK TRIPLE ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment 
Budpak 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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Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

Purpose

First Aid Antibiotic

Uses

first aid to help prevent infection in

Warnings

For external use only

Do not use

Ask a doctor before use on

Stop use and consult a doctor if the condition persists or gets worse, or if 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

Other Information

Inactive Ingredients

Cocoa butter, Petrolatum, Cottonseed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.

PRINCIPAL DISPLAY PANEL

Budpak Triple Antibiotic

First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

image of package label

BUDPAK TRIPLE ANTIBIOTIC MAXIMUM STRENGTH 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-024
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
COCOA BUTTER (UNII: 512OYT1CRR)  
PETROLATUM (UNII: 4T6H12BN9U)  
COTTONSEED OIL (UNII: H3E878020N)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM PYRUVATE (UNII: POD38AIF08)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-024-011 in 1 BOX
1NDC:27293-024-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/10/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-024)

Revised: 6/2013
Document Id: 668371ff-a1b5-4818-896f-425890f542e3
Set id: 55e236e6-48b8-4391-b60f-7dcc5b5ecff7
Version: 2
Effective Time: 20130611
 
Budpak Inc.