BACITRACIN- bacitracin ointment 
Blossom Pharmaceuticals

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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Bacitracin Ointment

Active ingredient                                                                    Purpose
Bacitracin Zinc (Equal to 500 Bacitracin Units)                          First Aid Antibiotic

Purpose:

First aid to help prevent infection.

Warnings:

For external use only

Dosage and Administration

Directions:

  • clean the affected areas
  • apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Indications and Usage

First aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

Stop Use and ask a doctor if:

  • the condition persists or gets worse, or if a rash or other allergic reaction develops.

Do Not Use if:

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

Ask a doctor before use:


Keep out of reach of children

Other information

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Bacitracin Ointment

BP Bacitracin.jpg

Bacitracin

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61767-219-0128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/06/2014
Labeler - Blossom Pharmaceuticals (677381470)
Establishment
NameAddressID/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(61767-219)

Revised: 3/2014
Document Id: e231c3af-75a8-42db-8a8c-743d92ec25d5
Set id: 54a400eb-a0e7-465f-9bc5-c526d169a961
Version: 1
Effective Time: 20140306
 
Blossom Pharmaceuticals