BACITRACIN ZINC ointment

BACITRACIN ZINC by

Drug Labeling and Warnings

BACITRACIN ZINC by is a Otc medication manufactured, distributed, or labeled by Direct_Rx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Bacitracin Zinc (equal to 500 bacitracin units)

PURPOSE

First Aid Antibiotic

STOP USE

■ the condition persists or gets worse

■ a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DO NOT USE

■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body longer than 1 week unless directed by a doctor

ASK DOCTOR

■ deep or puncture wounds

■ animal bites ■ serious burns

WARNINGS

For external use only

OTHER SAFETY INFORMATION

■ store at room temperature 15-30C (59-86F)

■ avoid excessive heat and humidity

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-044(NDC:52410-3035)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-044-30	1 g in 1 TUBE; Type 0: Not a Combination Product	10/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	10/09/2019

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct_Rx		079254320	repack(72189-044)