BACITRACIN ZINC- bacitracin zinc ointment 
Cardinal 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 Zinc Ointment

Active ingredient

Drug Facts: In each gram: Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

First Aid Antibiotic

Keep Out of Reach of Children

Keep out of the reach of children.

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only. This package is intended for institutional use only. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use in the eyes, over large areas of the body or 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 or if a rash or other allergic reaction develops.

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

Inactive ingredients

Mineral oil and white petrolatum

Storage

Store at Room Temperature

Other

This product available in tubes at pharmacy.

E. FOUGERA & CO.,

A division of Fougera Pharmaceuticals Inc.,

Melville, New York 11747

Questions or comments? call toll free 1-800-645-9833

fougera and FOILPACS are trademarks owned by their respective owners.

Repackaged By:

Cardinal Health

Zanesville, OH 43701

PR35882090816

LA60090613

Principal Display Panel

Bacitracin Zinc Ointment, USP

First Aid Antibiotic

6 Foilpacs® Net WT 0.9g (1/32 oz)

bag label

Principal Display Panel

Bacitracin Zinc Ointment, USP

First Aid Antibiotic

1 Foilpac® Net WT 0.9g (1/32 oz)

Bag Label
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0155(NDC:0168-0111)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-0155-56 in 1 BAG06/02/201101/31/2018
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:55154-0155-81 in 1 BAG06/02/201101/31/2017
20.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/02/201101/31/2018
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-0155)

Revised: 12/2017
 
Cardinal Health