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Bacitracin Zinc by Promex, LLC

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[USP'U] in 1g
Labeler: Promex, LLC
NDC Code: 58988-0031

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.

Drug Facts

Active ingredient (in each gram)

Bacitracin Zinc 500 units

Purpose

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
  • 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
  • clean the affected area
  • 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 20 - 25C (68 - 77F)

Inactive ingredients

light mineral oil, white petrolatum

Package label

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:58988-0031-11 TUBE (TUBE) 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
 
Promex, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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