TRIPLE ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc neomycin 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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Drug Facts

Active Ingredients
Bacitracin Zinc 400U
Neomycin 3.5mg
Polymyxin B sulfate 5000U

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  •in the eyes   •if you are allergic to any of the ingredients   •longer than 1 week unless directed by a doctor   •over large areas of the body

Ask a doctor before use on •on deep puncture wounds, animal bites, or serious burns

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
•Clean the affected area and dry thoroughly
•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 68 to 77F (20C-25C)  •See carton or tube crimp for lot number and expiration date

Inactive ingredients Petrolatum, Mineral oil, Ozocerite, Propanediol, Methylparaben, Propylparaben

Package Label
image of package label

TRIPLE ANTIBIOTIC  MAXIMUM STRENGTH
bacitracin zinc neomycin polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [USP'U]  in 1 g
NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPANEDIOL (UNII: 5965N8W85T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-014-011 in 1 BOX
1NDC:27293-014-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/19/2011
Labeler - Budpak Inc. (183224849)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Zhongbao Pharmaceutical Co., Ltd420795668manufacture

Revised: 8/2011
Document Id: 1feefbdd-7a58-4862-a59b-a3263051e67d
Set id: e7f5fdf0-1ce4-4f8b-af19-155690ca63be
Version: 1
Effective Time: 20110816
 
Budpak Inc.