ULTRA SEAL BACITRACIN- bacitracin zinc ointment

Ultra Seal Bacitracin by

Drug Labeling and Warnings

Ultra Seal Bacitracin by is a Otc medication manufactured, distributed, or labeled by Ultra Seal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

In Each Gram-Bacitracin Zinc 500 units

PURPOSE

Purpose: First Aid Antibiotic

INDICATIONS & USAGE

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

WARNINGS

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 REACH OF CHILDREN

Keep out of the reach of children

DOSAGE & ADMINISTRATION

 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

inactive Ingredient: White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA SEAL BACITRACIN  
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42213-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [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: 42213-400-28	1 in 1 CARTON	12/04/2011
1		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	12/04/2011

Labeler - Ultra Seal Corporation (085752004)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(42213-400)