BACITRACIN ZINC- bacitracin zinc ointment 
Delsam Pharma 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 Ointment USP

Drug Facts

Active ingredient (in each gram)

Bacitracin zinc. USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in • minor cuts • scrapes • burns

Warnings

For external use only

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

Do not use • in the eyes • over large areas of the body

Ask a doctor before use if you have • deep or puncture wounds • animal bites • 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 persists or gets worse • 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 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 ingredient

white petroleum Jelly

Other information

• Store at room temperature 59°-77°F (15°-25°C)

• Before using any medication, read all label directions. Keep carton, it contains important information.

Questions?

1-866-826-1306 between 9am and 4 pm EST, Monday-Friday.

Prevents Infection in Minor Cuts, Scrapes and Burns

This product is not manufactured or distributed by Johnson & Johnson Consumer Companies, Inc.. owner of the registered trademark Neosporin®

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

image description

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-108
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
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72570-108-301 in 1 CARTON09/25/2018
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/25/2018
Labeler - Delsam Pharma Llc (081369679)

Revised: 10/2018
Document Id: 97028ef2-f2bc-43d1-919e-e68167c85eaa
Set id: 62a35d36-3744-4cf4-a3cd-7f3d42fccc65
Version: 2
Effective Time: 20181009
 
Delsam Pharma Llc