SCHEIN BACITRACIN- bacitracin zinc ointment 
Henry Schein, Inc.

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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DRUG FACTS

In Each Gram-Bacitracin Zinc 500 units

In Each Gram-Bacitracin Zinc 500 units

Purpose: First Aid Antibiotic

 First Aid to help prevent infection in minor cuts, burns, scrapes

DO NOT USE:  In the eyes.  Over large areas of the body. If you are allergic to any of the ingredients due to the possibility of anaphylactic shock. Longer than 1 week unless directed by a doctor.

Stop use and ask a doctor before use: in the case of dep puncture wounds, animal bites, or serious burns.  If the condition persists or gets worse. If a rash or other allergic reaction develops.

If swallowed get medical help or contact a Poison Control Center immediately.



Keep out of the reach of children

 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 1-3 times daily

May be covered with a sterile bandage.

inactive Ingredient: White Petrolatum

hsBacitracinpacketcarton

SCHEIN BACITRACIN 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0400
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
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0400-47144 in 1 CARTON12/04/2011
1NDC:0404-0400-090.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0404-0400-481 in 1 CARTON12/04/2011
2NDC:0404-0400-2828 g in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00412/04/201101/01/2024
Labeler - Henry Schein, Inc. (012430880)
Registrant - ULTRAtab Laboratories, Inc. (151051757)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(0404-0400)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(0404-0400)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation944090448pack(0404-0400)

Revised: 1/2023
 
Henry Schein, Inc.