BACITRACIN by ALLIED TRADE LINK LLC / GOPALDAS VISRAM AND COMPANY LMITED BACITRACIN ointment

BACITRACIN by

Drug Labeling and Warnings

BACITRACIN by is a Otc medication manufactured, distributed, or labeled by ALLIED TRADE LINK LLC, GOPALDAS VISRAM AND COMPANY LMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGRIDIENT

Active Ingredient (in each gram) Purpose

Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

USES

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

WARNINGS

For External Use Only

DO NOT USE

Do not use In the eyes or 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

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

DO NOT USE

Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTION

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

Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature
See crimp of tube or carton for Lot Number and Expiry Date Preserve in well-closed containers, preferably at controlled room temperature.

INACTIVE INGREDIENTS

Mineral Oil, Paraffin, White Petrolatum

dosage and administration

Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by
a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting,
ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for
2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails

Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

Active Ingredient (in each gram) Purpose
Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84387-002
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84387-002-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	10/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	10/24/2024

Labeler - ALLIED TRADE LINK LLC (029033682)

Registrant - ALLIED TRADE LINK LLC (029033682)

Establishment
Name	Address	ID/FEI	Business Operations
GOPALDAS VISRAM AND COMPANY LMITED		858030888	manufacture(84387-002)