BACITRACIN ZINC - bacitracin zinc ointment 
Kareway Product, 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 ingredient (in each gram)

Bacitracin Zinc 500 units

Purpose

First aid antibiotic

Uses

helps prevent infection in

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

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.

Directions

Other information

Inactive ingredients

light mineral oil, white petrolatum

Package label

Bacitracin Zinc Ointmentimage of carton label

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0055-11 in 1 CARTON
128 g in 1 TUBE
2NDC:67510-0055-51 in 1 CARTON
214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/24/2012
Labeler - Kareway Product, Inc. (121840057)

Revised: 7/2012
Document Id: 64e859d4-1ed6-4b9f-9dbe-dd45ef7aa1b2
Set id: 52621048-fc8d-461a-8c0f-e3ba16dd20d0
Version: 1
Effective Time: 20120716
 
Kareway Product, Inc.