Antibiotic: Package Insert and Label Information

ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
Cardinal Health (Leader) 70000

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 (in each gram)

Bacitracin zinc, USP 500 units
Polymyxin B sulfate, USP 10,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients

Do not use

  • 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

When using this product

  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • 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 (1-800-222-1222) right away.

Directions

  • clean 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 15º-25ºC (59º-77ºF)
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

COMPARE TO POLYSPORN® active ingredients*

For External Use Only

Dual Action

First Aid to Help Prevent Infection in

Minor Cuts, Scrapes, and Burns

Protection Against Infection

Poly Bacitracin

Bacitracin Zinc USP | Polymyxin B Sulfate

First Aid Antibiotic Ointment

*This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Polysporin®.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package label

Bacitrain zinc, USP 500 units, Polymyxin B sulfate, USP 10,000 Units
(click image for full-size original)

LEADER Poly Bacitrain

ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0070
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [iU] in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0070-1 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (70000-0070-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 12/31/2020
Labeler — Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022 Cardinal Health (Leader) 70000

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