BACITRACIN ZINC- bacitracin zinc ointment 
GERITREX 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 USP Ointment

Active Ingredient:                                                 Purpose:

Bacitracin Zinc  500 units (each gram)....................First Aid Antibiotic

Uses:

Helps prevent infection in: Minor cuts, scrapes, and/or burns

Warnings:

FOR EXTERNAL USE ONLY
Allergy Alert: Do not use if allergic to any of the ingredients.
Do not use in eyes or on large areas of the body.
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
When using this product, do not use longer than 1 week, unless directed by a doctor.
Stop use and ask a doctor if condition lasts or gets worse, rahs or other allergic reaction develops.

KEEP OUT OF REACH OF CHILDREN
In the event of accidental ingestion, contact a Poison Control Center right away.

Directions:

Clean affected area. Apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily. May be covered with a sterile bandage.

Inactive Ingredients:

Mineral Oil and White Petrolatum

Other Information:

Store at controlled room temperature
59°-86°F (15°-30°C).

09

15

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BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-017-1515 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
2NDC:54162-017-2828 g in 1 TUBE; Type 0: Not a Combination Product11/01/2017
3NDC:54162-017-090.9 g in 1 POUCH; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/15/2014
Labeler - GERITREX LLC (112796248)
Registrant - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX LLC112796248manufacture(54162-017)

Revised: 1/2018
Document Id: e9705790-82fd-4d43-9438-5a3e88ba9a67
Set id: ab757ae5-108d-418b-b37c-e46c3ff37fbc
Version: 6
Effective Time: 20180117
 
GERITREX LLC