Bacitracin by BluePoint Laboratories / Gopaldas Visram & Co., Ltd BACITRACIN ointment

Bacitracin by

Drug Labeling and Warnings

Bacitracin by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, Gopaldas Visram & Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Bacitracin (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 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.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Centre 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

• 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

Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Questions?

Contact- 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited,

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 09/2021

Principal Display Panel

Bacitracin sachet and carton 0.9g

PRINCIPAL DISPLAY PANEL

Bacitracin tube and carton 14.2g

PRINCIPAL DISPLAY PANEL

Bacitracin 28.4g tube and carton

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-477
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-477-48	1 in 1 CARTON	11/24/2020
1	NDC: 68001-477-45	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 68001-477-46	1 in 1 CARTON	11/24/2020
2		14.2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68001-477-47	1 in 1 CARTON	11/24/2020
3		28.4 g 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 Drug	M004	11/24/2020

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-477)