BACITRACIN- bacitracin zinc cream 
HART Health

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 Ingredients (in each gram):

Bacitracin zinc 500 units

Purpose:

Topical Antibiotic

Uses: First aid to help prevent infection in

Warnings: For external use only

Allergy alert: do not use if you are allergic to any of the ingredients

Do not use:

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222.

Directions: do not use more than directed

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

Inactive Ingredients: petrolatum

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BACITRACIN 
bacitracin zinc cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 U  in 0.9 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0030-4144 in 1 BOX, UNIT-DOSE01/05/2021
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/05/2021
Labeler - HART Health (069560969)
Registrant - HART Health (069560969)
Establishment
NameAddressID/FEIBusiness Operations
WaterJel Technologies155522589manufacture(50332-0030)

Revised: 11/2022
Document Id: fbf77870-746d-4e3e-bcad-1ce7133a30bb
Set id: 3d8918c6-f675-498a-8c97-e6b747f66e2d
Version: 2
Effective Time: 20221122
 
HART Health