Bacitracin 500units by Pharmaceutica North America, Inc.

Drug Details [pdf]

BACITRACIN 500UNITS- bacitracin ointment
Pharmaceutica North America, Inc.

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Active Ingredient

Bacitracin 500 units

Purpose

First aid antibiotic

Uses

temporarily relieves minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
sprains

Warnings

For external use only.
Do not use
in the eyes
on large areas of the body
if you are allergic to any of the ingredients
Ask a doctor before use if you have
deep or puncture wounds
animal bites
serious burns
Stop use and ask a doctor if
you need to use longer than 1 week
condition persists or gets worse
rash or other allergic reaction develops
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) 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 20° - 25°C (68° - 77°F)

Inactive Ingredients

light mineral oil, white petrolatum

Questions or comments? 1-888-788-6472

Product label

image description

BACITRACIN 500UNITS
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-073
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 45861-073-03	30 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M004	02/01/2025	12/31/2025

Labeler - Pharmaceutica North America, Inc. (962739699)

Revised: 12/2025

Document Id: 471bdf68-b865-096f-e063-6294a90a84d1

Set id: b8d44e8a-c36a-4b12-9b76-ba6f0d653455

Version: 2

Effective Time: 20251229