TRIPLE ANTIBIOTIC- triple antibiotic ointment 
ProStat First Aid

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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2009 Triple Antibiotic

Active Ingredient (in each gram)

Bacitracin Zinc 400 Units

Active Ingredient

Neomycin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)

Active Ingredient (in each gram)

Polymyxin B Sulfate 5000 Units

Purpose

First Aid Antibiotic

Use(s)

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For External Use Only

Do not use

• In the eyes or apply over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Ask a doctor before use if

you have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

• The condition persists or gets worse

• A rash or other allergic reaction develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Clean the affected area. Apply a small amount of the 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 room temperature between 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if packet is torn, cut, or opened.

Inactive Ingredient

White Petrolatum

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST

Label

PS-2009-BX-MASTERTriple Antibiotic Ointment

TRIPLE ANTIBIOTIC 
triple antibiotic ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58228-2009-21800 in 1 CASE04/10/2023
1NDC:58228-2009-125 in 1 BOX
10.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/10/2023
Labeler - ProStat First Aid (061263699)

Revised: 3/2023
Document Id: f76d7d18-0fa2-d943-e053-6294a90ac20a
Set id: f76d7d18-0fa1-d943-e053-6294a90ac20a
Version: 1
Effective Time: 20230321
 
ProStat First Aid