TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl ointment

TRIPLE ANTIBIOTIC by

Drug Labeling and Warnings

TRIPLE ANTIBIOTIC by is a Otc medication manufactured, distributed, or labeled by Encube Ethicals, Inc., Encube Ethicals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each gram)

Bacitracin zinc USP, 500 units

Neomycin 3.5 mg

Polymyxin B sulfate USP, 10,000 units

Pramoxine hydrochloride USP, 10 mg

Purposes

First aid antibiotic

Pain reliever

Uses

First aid to help prevent infection for the temporary relief of pain in minor ■ burns ■ cuts ■ scrapes

Warnings

For external use only.

Do not use

■ if you are allergic to any of the ingredients

■ in the eyes

■ over large areas of the body

Ask a doctor before use if you have

■ deeper puncture wounds

■ animal bites

■ serious bums

Stop use and ask doctor if

■ you need to use longer than one week

■ condition persists or gets worse
■ rash or other allergic reaction develops 
■ symptoms persist for more than one week, or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

■ adults and children 2 years of age and older
■ 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
■ children under 2 years of age: ask a doctor

Other information

■ store at 15°G to 30°C (59°F to 86°F)
■ before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions or comments?

Call - 1-833-285-4151 Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

Triple Antibiotic

Ointment + Pain Relief

NET WT. 0.5 OZ (14 g)

Triple Antibiotic

Ointment + Pain Relief

NET WT. 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21922-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  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: 21922-101-04	1 in 1 CARTON	03/06/2025
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 21922-101-05	1 in 1 CARTON	03/06/2025
2		28 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	03/06/2025

Labeler - Encube Ethicals, Inc. (116982244)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Private Limited		725076298	analysis(21922-101) , label(21922-101) , manufacture(21922-101) , pack(21922-101)