BACITRACIN by DIRECT RX BACITRACIN ointment

BACITRACIN by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Bacitracin 500 units

PURPOSE

First aid antibiotic

WHEN USING

first aid to help prevent infection in:

minor cuts

scrapes

burns

WARNINGS

For external use only

Do not use

in the eyes

over 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 right away. (1-800-222-1222)

QUESTIONS

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

ASK DOCTOR

store at 20°-25°C (68°-77°F)

DOSAGE & ADMINISTRATION

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INACTIVE INGREDIENT

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INDICATIONS & USAGE

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KEEP OUT OF REACH OF CHILDREN

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-116(NDC:45802-060)
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-116-30	1 g in 1 CARTON; Type 0: Not a Combination Product	03/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	03/27/2017

Labeler - DIRECT RX (079254320)

Registrant - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	repack(61919-116)