Bacitracin by Dynarex Corporation BACITRACIN ointment

Bacitracin by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Bacitracin (500 units in each gram)

Purpose

First Aid Antibiotic

Use

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

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

Inactive ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

1162 Label

1161 Label

1163 Label

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500   in 1000 mg

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-116-10	1728 in 1 CASE	09/12/2016
1		144 in 1 BOX
1		900 mg in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-116-30	72 in 1 CASE	09/12/2016
2		1 in 1 BOX
2		28400 mg in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 67777-116-20	72 in 1 CASE	09/12/2016
3		14000 mg 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	09/12/2016

Labeler - Dynarex Corporation (008124539)