SPL v2
SPL
SPL Set ID 3335cdea-f7ff-4e0c-aadf-9e9e4fd64be1
Route
TOPICAL
Published
Effective Date 2019-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Polymyxin B (5000 [USP'U]) Neomycin (3.5 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-01-23
Description

Drug Facts

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic

Medication Information

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Description

Drug Facts

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Warnings

For external use only

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
Do Not Use
  • in or near the eyes
  • on large areas of the body
Allergy Alert:
  • do not use if you are allergic to any of the ingredients
Other Information
  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
Inactive Ingredient

Petrolatum

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

Welly  First Aid    NDC 72663-162-58

Bravery Balm

Triple Action First aid Antibiotic Ointment 

NET WT 0.50 oz (14g)

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

Principal Dispaly Panel Tube 

Welly First aid NDC 72663-162-58

Triple Action First Aid Antibiotic Ointment  

NET WT 0.5 oz (14g)

Bacitracin Zinc, Neomycin Sulfate, Polymixin B Sulfate 

Stop Use and Consult A Doctor If
  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction develops
Active Ingredients (in Each Gram)

Bacitracin 400

Neomycin 3.5 mg

Polymyxin B 5,000 units

Consult A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns

Structured Label Content

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Warnings

For external use only

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
Do Not Use (Do not use)
  • in or near the eyes
  • on large areas of the body
Allergy Alert: (Allergy alert:)
  • do not use if you are allergic to any of the ingredients
Other Information (Other information)
  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
Inactive Ingredient (Inactive ingredient)

Petrolatum

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

Welly  First Aid    NDC 72663-162-58

Bravery Balm

Triple Action First aid Antibiotic Ointment 

NET WT 0.50 oz (14g)

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

Principal Dispaly Panel Tube  (Principal Dispaly Panel -Tube )

Welly First aid NDC 72663-162-58

Triple Action First Aid Antibiotic Ointment  

NET WT 0.5 oz (14g)

Bacitracin Zinc, Neomycin Sulfate, Polymixin B Sulfate 

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction develops
Active Ingredients (in Each Gram) (Active ingredients (In each gram))

Bacitracin 400

Neomycin 3.5 mg

Polymyxin B 5,000 units

Consult A Doctor Before Use If You Have (Consult a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:45.646583 · Updated: 2026-03-14T22:55:26.303656