BACITRACIN ZINC- bacitracin zinc ointment 
H2-Pharma, 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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Bacitracin Zinc Ointment

Drug Facts

Active ingredient (in each gram)

Bacitracin zinc USP, 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor

Warnings

For external use only.

Do not use

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

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 one week
  • 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 right away.

Directions

Other information

Inactive ingredient

white petrolatum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

NDC 61269-105-34

Bacitracin Zinc Ointment, USP
First aid antibiotic

For external use only
First aid antibiotic to help prevent infection in minor cuts, scrapes, and burns

Net wt. 0.5 oz (14 g)

H2 pharma

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-105
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Product Characteristics
ColorWHITE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61269-105-341 in 1 CARTON05/10/202107/31/2024
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:61269-105-561 in 1 CARTON06/29/202110/31/2024
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B05/10/202110/31/2024
Labeler - H2-Pharma, LLC (028473634)

Revised: 2/2023
Document Id: 0f6793ee-6f8a-4afb-8ba5-44345960859b
Set id: 15eb3bf2-3a89-4381-8b05-9a123ec04dd1
Version: 5
Effective Time: 20230207
 
H2-Pharma, LLC