DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment 
Rugby Laboratories, 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.

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Poly Antibiotic Ointment - Bacitracin Zinc, Polymyxin B Sulfate

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

  • minor 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

  • 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 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 15° to 25°C (59° to 77°F).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

Principal Display Panel

Rugby®

Compare to the active ingredients in Polysporin®*

NDC 0536-1174-20

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment, USP)

First Aid Antibiotic

First Aid to Help Prevent Infection in Minor Cuts, Scrapes, and Burns

Net wt. 0.5 oz (14g)

• Protection Against Infection
• For Minor Cuts, Scrapes, and Burns
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DOUBLE ANTIBIOTIC 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1174
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1174-201 in 1 CARTON03/20/201906/28/2022
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0536-1174-281 in 1 CARTON03/25/201906/28/2022
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/20/201906/28/2022
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 12/2022
Document Id: 3e377dda-57b6-4dfe-b931-821e32f86c3c
Set id: 5aef8842-099b-41b6-b2a1-04a01317467a
Version: 6
Effective Time: 20221216
 
Rugby Laboratories, Inc.