ea0142f7-a622-4981-847c-8af76263ee34

SPL v3
SPL
SPL Set ID ea0142f7-a622-4981-847c-8af76263ee34
Route
topical
Published
Effective Date 2022-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (500 [USP'U]) polymyxin b (10000 [USP'U])
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-01
Purpose

First aid antibiotic

Description

Bacitracin 500 units Polymyxin B Sulfate 10,000 units

Medication Information

Warnings

For external use only

Allergy alert: 

  • do not use if you are allergic to any of the ingredients
Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

Directions
  • clean the affected area
  • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage
Description

Bacitracin 500 units Polymyxin B Sulfate 10,000 units

Section 50565-1

Keep out of the reach of children.

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

Do Not Use 
  • in or near the eyes
  • on large areas of the body
Drug Facts 

Inactive Ingredient 

Petrolatum 

When Using This Product 
  • do not use longer than 1 week
Principal Display Panel Tube

Double Antibiotic Ointment       NDC 11822-0093-5

Bacitracin Zinc - 500 Bacitracin units

Polymixin B Sulfate - 10,000 units 

First Aid Antibiotic 

NET WT 0.5oz (14g)

Active Ingredients (in Each Gram)

Bacitracin 500 units

Polymyxin B Sulfate 10,000 units

Principal Display Panel Carton 

Double Antibiotic Ointment NDC 11822-0093-5

Bacitracin Zinc - 500 Bacitracin units

Polymixin B Sulfate - 10,000 units

First Aid Antibiotic

NET WT 0.5oz (14g)

Consult A Doctor Before Use If You Have

deep or puncture wounds

animal bites

serious burns

Store At A Controlled Room Temperature 20º 25ºc (68° to 77°f)

Structured Label Content

Warnings

For external use only

Allergy alert: 

  • do not use if you are allergic to any of the ingredients
Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

Directions
  • clean the affected area
  • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage
Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Do Not Use  (Do not use )
  • in or near the eyes
  • on large areas of the body
Drug Facts 

Inactive Ingredient  (Inactive ingredient )

Petrolatum 

When Using This Product  (When using this product )
  • do not use longer than 1 week
Principal Display Panel Tube (Principal display panel -Tube)

Double Antibiotic Ointment       NDC 11822-0093-5

Bacitracin Zinc - 500 Bacitracin units

Polymixin B Sulfate - 10,000 units 

First Aid Antibiotic 

NET WT 0.5oz (14g)

Active Ingredients (in Each Gram) (Active ingredients (In each gram))

Bacitracin 500 units

Polymyxin B Sulfate 10,000 units

Principal Display Panel Carton  (Principal Display Panel -Carton )

Double Antibiotic Ointment NDC 11822-0093-5

Bacitracin Zinc - 500 Bacitracin units

Polymixin B Sulfate - 10,000 units

First Aid Antibiotic

NET WT 0.5oz (14g)

Consult A Doctor Before Use If You Have (Consult a doctor before use if you have)

deep or puncture wounds

animal bites

serious burns

Store At A Controlled Room Temperature 20º 25ºc (68° to 77°f) (Store at a controlled room temperature 20º-25ºC (68° to 77°F))

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:30.097662 · Updated: 2026-03-14T23:05:17.700396