ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

ANTIBIOTIC by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Active Ingredient (in each gram)

Bacitracin Zinc, USP            500 units

Neomycin                             3.5mg 

Polymyxin B Sulfate, USP   10,000 units

PURPOSE

First aid antibiotic

USE(S)

First aid to help prevent infection in minor

• cuts
• scrapes
• burns

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

■ deep or puncture wounds

■ animal bites

■ serious burns

STOP USE AND ASK A DOCTOR IF

■ you need to use longer than one 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 (1-800-222-1222) 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

■ store at 15°-30°C (59°-86°F). Protect from freezing.

■ 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

INGREDIENTS AND APPEARANCE

ANTIBIOTIC  MAXIMUM STRENGTH
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU]  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 [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: 0363-1331-01	1 in 1 CARTON	01/29/2025
1		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	01/29/2025

Labeler - Walgreens Co. (008965063)

Registrant - Encube Ethicals Private Limited (915834105)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Private Limited		725076298	ANALYSIS(0363-1331) , LABEL(0363-1331) , MANUFACTURE(0363-1331) , PACK(0363-1331)