BACITRACIN ZINC- bacitracin zinc ointment 
Promex, LLC

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

 First aid to help prevent infection in minor:

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

When using this product

  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • condition persists or gets worse
  • a rash or other allergic reaction develops

Keep out of reach of children

In case of accidental Ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

store at 20 - 25C (68 - 77F)

Inactive ingredients

light mineral oil, white petrolatum

Package label

image of carton label

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58988-0031-11 in 1 CARTON
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/02/2013
Labeler - Promex, LLC (789974388)

Revised: 12/2013
Document Id: f1eac575-6602-4a06-a863-647497d835f0
Set id: f1f7ba23-6a90-4eaa-8eeb-d73db774b863
Version: 2
Effective Time: 20131210
 
Promex, LLC