Triple Antibiotic: Package Insert and Label Information

TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Ezricare 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.

Drug Facts

Active ingredients

Bacitracin Zinc (400 units in each gram)
Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin per gram)
Polymyxin B Sulfate (5000 units per gram)

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 have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if • the condition persists or get’s worse, or if 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

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature
• Preserve in well-closed containers • See crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredient

White Petrolatum

Questions or comments?

718-502-6610 between 9 am to 4 pm EST, Monday-Friday.

Distributed by:

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Packaging

Ezri-108
(click image for full-size original)

TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79503-108
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 400 [iU] in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 5000 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
WHITE PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79503-108-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (79503-108-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 09/01/2021
Labeler — Ezricare Llc (117573818)

Revised: 09/2021 Ezricare Llc

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