BACITRACIN ZINC ointment

Bacitracin Zinc by

Drug Labeling and Warnings

Bacitracin Zinc by is a Otc medication manufactured, distributed, or labeled by GERITREX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:                                                 Purpose:

Bacitracin Zinc  500 units (each gram)....................First Aid Antibiotic

Uses:

Helps prevent infection in: Minor cuts, scrapes, and/or burns

INDICATIONS & USAGE

Warnings:

FOR EXTERNAL USE ONLY
Allergy Alert: Do not use if allergic to any of the ingredients.
Do not use in eyes or on large areas of the body.
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
When using this product, do not use longer than 1 week, unless directed by a doctor.
Stop use and ask a doctor if condition lasts or gets worse, rahs or other allergic reaction develops.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN
In the event of accidental ingestion, contact a Poison Control Center right away.

Directions:

Clean affected area. Apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily. May be covered with a sterile bandage.

Inactive Ingredients:

Mineral Oil and White Petrolatum

STORAGE AND HANDLING

Other Information:

Store at controlled room temperature
59°-86°F (15°-30°C).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-017
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-017-15	15 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2015
2	NDC: 54162-017-28	28 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2017
3	NDC: 54162-017-09	0.9 g in 1 POUCH; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	05/15/2014

Labeler - GERITREX LLC (112796248)

Registrant - GERITREX LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
GERITREX LLC		112796248	manufacture(54162-017)