SINGLE 0.9G TRIPLE ANTIBIOTIC- bacitracin zinc 400 units ointment

Single 0.9g Triple Antibiotic by

Drug Labeling and Warnings

Single 0.9g Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Sled Distribution, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neoycin sulfate (neoycin 3.5 mg)

Polymyxin B sulfate

(polymyxin B 5,000 units)

Purpose

Bacitracin Zinc 400 units........First aid antibiotic

Uses

First aid to help prevent infection in

• minor cuts
• scrapes
• burns

Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body
• if you are allergic to any of the ingredients
• longer than 1 week unless directed by doctor

Ask a doctor before use if

• on deep or puncture wounds, animal bites, or serious burns

Stop use and ask doctor if

• condition persists or gets worse
• a rash or other allergic reaction develops

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

• Store at room temperature

Inactive ingredients

Mineral oil, Petrolatum, Purified water

Principal Display Panel

OINTMENT

INGREDIENTS AND APPEARANCE

SINGLE 0.9G TRIPLE ANTIBIOTIC 
bacitracin zinc 400 units ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81417-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	0.0035 g  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81417-108-01	1 in 1 CARTON	01/08/2021
1		0.9 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 final	part333B	01/08/2021

Labeler - Sled Distribution, LLC (079772888)

Establishment
Name	Address	ID/FEI	Business Operations
Sled Distribution, LLC		079772888	manufacture(81417-108)