3335cdea-f7ff-4e0c-aadf-9e9e4fd64be1

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

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

First aid antibiotic

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
Other Information
  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
Description

Drug Facts

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.

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
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

Warnings

For external use only

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

First aid antibiotic

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
Other Information (Other information)
  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
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.

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
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)