SCHEIN TRIPLE ANTIBIOTIC- neomycin sulfate, polymyxin b sulfate, 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.

----------

DRUG FACTS

Actve Ingredients: In each gram-Neomycin Sulfate-5 mg (equivalent to 3.5 mg Neomycin), Polymyxin B Sulfate-5000 I.U., Bacitracin Zinc-400 I.U.

PURPOSE: First aid antibiotic

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

For external use only. Do not use on eyes. Do not use if you are allergic to any of the ingredients due to the possibility of anaphylactic shock.

Stop use and ask a doctor before use in cases of deep puncture wounds, animal bites, serious burns; if the condition persists or gets worse; if a rash or other allergic reaction developes

If swallowed get medical help or contact a poison control center right away

KEEP OUT OF THE REACH OF CHILDREN

Clean the affected area. apply a small amount of 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

Schein Triple carton

SCHEIN TRIPLE ANTIBIOTIC 
neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0360-47144 in 1 BOX04/21/2015
1NDC:0404-0360-090.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0404-0360-481 in 1 CARTON04/21/2015
2NDC:0404-0360-2828 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/21/2015
Labeler - Henry Schein, Inc. (012430880)
Registrant - Ultraseal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(0404-0360)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(0404-0360)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation944090448pack(0404-0360)

Revised: 10/2019
 
Henry Schein, Inc.