DG Health Poly Antibiotic: Package Insert and Label Information

DG HEALTH POLY ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
Dolgencorp, Inc.

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 ingredients (in each gram) Purpose

Bacitracin 500 units………………………………………. First aid antibioitic

Polymyxin B 10,000 units……………………………….. First aid antibiotic

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 or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• you need to use longer than 1 week
• condition persits or gets worse
• 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 20° to 25°C (68° to 77°F)
• lot no. & exp. date: see box or see crimp of tube

Inactive ingredient: white petrolatum base

Distributed by:

Dolgencorp, LLC

100 Mission Ridge

Goodlettsville, TN 37072

Made in Korea

DG HEALTH POLY ANTIBIOTIC bacitracin, and polymyxin b ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-586 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55910-586-14 1 TUBE in 1 CARTON contains a TUBE 1 14 g in 1 TUBE This package is contained within the CARTON (55910-586-14)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/11/2016

Labeler — Dolgencorp, Inc. (068331990)

Revised: 08/2016 Dolgencorp, Inc.