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Bacitracin Zinc by GERITREX LLC

Medically reviewed on January 17, 2018

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[iU] in 1g
Labeler: GERITREX LLC
NDC Code: 54162-017

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.

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).

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-017
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:54162-017-1515 g in 1 TUBE
2NDC:54162-017-2828 g in 1 TUBE
3NDC:54162-017-090.9 g in 1 POUCH
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/FEIOperations
GERITREX LLC112796248manufacture(54162-017)

 
GERITREX 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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