BACITRACIN ZINC- first aid antibiotic ointment

Bacitracin Zinc by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Bacitracin Zinc (500 units in each gram)

Purpose

First Aid Antibiotic

Uses

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

Warnings

For external use only

Do not use

• In the eyes or apply over large areas of the body
• If you are allergic to any of the ingredients
• Longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

the condition persists or gets worse, or if a rash or other allergic reaction develops

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 to 3 times daily. May be covered with a sterile bandage.

Other Information

• Store at room temperature
• Avoid excessive heat and humidity
• Tamper Evident. Do not use if inner seal is torn, cut or opened.

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

1171 Label

1172 Label

1173 Label

1175 Label

1176 Label

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
first aid antibiotic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-008
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-008-10	1728 in 1 CASE	02/16/2018
1		144 in 1 BOX
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-008-20	72 in 1 CASE	02/16/2018
2		1 in 1 BOX
2		14.2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 67777-008-30	72 in 1 CASE	02/16/2018
3		1 in 1 BOX
3		28.4 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 67777-008-50	72 in 1 CASE	02/16/2018
4		1 in 1 BOX
4		113 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 67777-008-60	12 in 1 CASE	02/16/2018
5		425 g in 1 JAR; 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	02/16/2018

Labeler - Dynarex Corporation (008124539)