SCHEIN TRIPLE ANTIBIOTIC- neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment

Schein Triple Antibiotic by

Drug Labeling and Warnings

Schein Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Henry Schein, Inc., Ultraseal Corporation, Ultra Seal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE: First aid antibiotic

INDICATIONS & USAGE

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

WARNINGS

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 REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT: WHITE PETROLATUM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SCHEIN TRIPLE ANTIBIOTIC 
neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0360-47	144 in 1 BOX	04/21/2015
1	NDC: 0404-0360-09	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0404-0360-48	1 in 1 CARTON	04/21/2015
2	NDC: 0404-0360-28	28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/21/2015

Labeler - Henry Schein, Inc. (012430880)

Registrant - Ultraseal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(0404-0360)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(0404-0360)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		944090448	pack(0404-0360)