TRIPLE ANTIBIOTIC PLUS LIDOCAINE- bacitracin zinc, neomycin sulfate , polymyxin b sulfate, lidocaine ointment

Triple Antibiotic plus Lidocaine by

Drug Labeling and Warnings

Triple Antibiotic plus Lidocaine by is a Otc medication manufactured, distributed, or labeled by TRIFECTA PHARMACEUTICALS USA LLC, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (each gram contains)

Bacitracin zinc 500 units
Neomycin sulfate 3.5 mg
Polymyxin B sulfate 10,000 units

Purpose

First aid antibiotic

Active Ingredient

Lidocaine 40mg

Purpose

External Analgesic

Uses

Uses first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:● cuts ● scrapes ● burns

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.

Warnings

For external use only.

Ask Doctor Before use if you have

Ask Doctor before use if you have

• Deep or puncture wounds
• Animal bites
• serious burns

Do Not Use

Do Not Use

• If you are allergic to any of the ingredients
• In the eyes
• Over large areas of the body
• In large quantities, particularly over raw surfaces or blistered areas

Stop Use and Ask a doctor if

Stop Use and Ask a doctor if

• You need to use longer than 1 week
• Condition persists or gets worse
• Symptoms persist for more than 1 week or clear up and occur again within a few days
• Rash or other allergic reaction develops

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

Questions

Questions? Call 1-888-296-9067

Inactive Ingredient

Petrolatum

Other information

● store at 20° to 25°C ( 68° to 77°F)

Distributed By

Distributed by:
Trifecta Pharmaceuticals USA®
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067

* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® plus Lidocaine

Lidocaine known to numb in 30 to 60 minutes.

Package Label

Label

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS LIDOCAINE 
bacitracin zinc, neomycin sulfate , polymyxin b sulfate, lidocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-154
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
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-154-01	1 in 1 BOX	03/31/2024
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-154-22	2 in 1 BOX	06/26/2024
2		28.4 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69396-154-44	4 in 1 BOX	03/31/2024
3		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	03/31/2024

Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)