TRIPLE ANTIBIOTIC- first aid antibiotic ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Bacitracin Zinc (400 units in each gram)

Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

Polymyxin B Sulfate (5000 units per gram)

Purpose

First Aid Antibiotics

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 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

WHEN USING

Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

STOP USE

Stop use and ask a doctor ifthe 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.

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 temperatue
• Preserve in well-closed containers
• See crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredients

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.L.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 09/2021

Package Label - Principal Display Panel

Triple Antibiotic Ointment 0.5 oz NDC: 68001-483-46

Triple Antibiotic Ointment 1 oz 68001-483-45

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
first aid antibiotic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-483-46	1 in 1 CARTON	06/15/2021
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68001-483-45	1 in 1 CARTON	06/15/2021
2		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	06/15/2021

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co Ltd		858030888	manufacture(68001-483)