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Bacitracin Zinc by H.J. Harkins Company, Inc.

Medically reviewed on August 21, 2017

Dosage form: ointment
Ingredients: Bacitracin Zinc 500[USP'U] in 1g
Labeler: H.J. Harkins Company, Inc.
NDC Code: 52959-113

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 Ointment USP

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

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 in case of 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 the condition persists or gets worse if 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 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 room temperature

Inactive ingredient white petrolatum

E. FOUGERA and CO.
a division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

Repacked by:
H.J. Harkins Company Inc.
Nipomo, CA 93444

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-113(NDC:0168-0011)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin Zinc) Bacitracin Zinc500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:52959-113-0328.34 g in 1 TUBE
2NDC:52959-113-1514.17 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/08/2010
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - Nycomed US Inc. (043838424)
Establishment
NameAddressID/FEIOperations
Nycomed US Inc.174491316MANUFACTURE
Establishment
NameAddressID/FEIOperations
Nycomed US Inc.043838424ANALYSIS, MANUFACTURE

 
H.J. Harkins Company, Inc.

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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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