Drug Facts

Active Ingredients (in each gram)

Bacitracin Zinc (400 units)

Neomycin Sulfate 5mg (3.5mg Neomycin)

Polymyxin B Sulfate (5000 units)

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 the 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 havedeep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor ifthe 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 (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

White Petrolatum

Principal Display Panel – 1 oz. Tube Label

Safetec®

Triple Antibiotic Ointment

First Aid Infection Protection

Net Wt. 1 oz. (28.4g)

Reorder No. 53207

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/503

TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61010-4400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61010-4400-1	28.4 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M004	11/01/2019

Labeler - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	manufacture(61010-4400)

61010-4400-1, Triple Antibiotic tube