Doubleantibioticointment: Package Insert and Label Information

DOUBLEANTIBIOTICOINTMENT- polymyxin b sulfate and bacitracin zinc ointment
Trifecta Pharmaceuticals USA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Bacitracin 500 Units

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B

Purpose

First Aid Double Antibiotic Ointment

Uses

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 puncture wounds
• animal bites
• serious burns

Stop use and ask doctor if:

• You need to use longer than 1 week
• Condition persists or gets worse
• rash or other allergic reaction develops

If swallowed, get medical help or contact a Poison Control Center immediately.

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 between 20° to 25°C (68° to 77°F)

Inactive Ingredients

White Petrolatum

Questions?

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL, 33301, USA

1-888-296-9067

www.trifecta-pharma.com

Product of PRC

This product is not manufactured or distributed by Johnson & Johnson Consumer Products company, owner of the registered trademark Polysporin®

DOUBLEANTIBIOTICOINTMENT bacitracin zinc, polymyxin b sulfate ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-029 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP’U] in 1 g BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g

Inactive Ingredients Ingredient Name Strength PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69396-029-30 1 TUBE in 1 BOX contains a TUBE 1 28 g in 1 TUBE This package is contained within the BOX (69396-029-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 05/04/2017

Labeler — Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 01/2021 Trifecta Pharmaceuticals USA LLC