SPL v1
SPL
SPL Set ID 5f1491f0-abea-4852-93f3-d5b22c3c5a94
Route
TOPICAL
Published
Effective Date 2014-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Polymyxin B (10000 [USP'U]) Neomycin (3.5 mg) Pramoxine (10 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-05-16

Description

Drug Facts

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic Pain reliever


Medication Information

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Description

Drug Facts

Uses

First aid helps prevent infection in and temporarily relieves pain due to:

  • 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

Allergy Alert:  Do not use if allergic to any of the ingredients

Directions

Adults and children 2 years and older.

  • 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

Children 2 years and under ask a doctor

Do Not Use
  • in or near the eyes or nose
  • on large areas of the body
Other Information
  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
Inactive Ingredient

White Petrolatum

When Using This Product
  • do not use longer than 1 week
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 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg

Principal Display Panel – Tube Label

POMADA DE LA CAMPANA

Originial Ointment

First Aid Antibiotic + Pain Relief Ointment

Triple Antibiotic + Pain Relief

  • Bacitracin Zinc
  • Neomycin Sulfate 
  • Polymixin B Sulfate
  • Pramoxine HCL

NET WT. 0.5 oz ( 14g)

 

 

 

 



 

Consult A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel – Carton Label

POMADA DE LA CAMPANA

Originial Ointment 

First Aid Antibiotic + Pain Relief Ointment

NET WT. 0.5 oz ( 14g)


Structured Label Content

Uses

First aid helps prevent infection in and temporarily relieves pain due to:

  • 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

Pain reliever

Warnings

For external use only

Allergy Alert:  Do not use if allergic to any of the ingredients

Directions

Adults and children 2 years and older.

  • 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

Children 2 years and under ask a doctor

Do Not Use (Do not use)
  • in or near the eyes or nose
  • on large areas of the body
Other Information (Other information)
  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
Inactive Ingredient (Inactive ingredient)

White Petrolatum

When Using This Product (When using this product)
  • do not use longer than 1 week
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 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg

Principal Display Panel – Tube Label

POMADA DE LA CAMPANA

Originial Ointment

First Aid Antibiotic + Pain Relief Ointment

Triple Antibiotic + Pain Relief

  • Bacitracin Zinc
  • Neomycin Sulfate 
  • Polymixin B Sulfate
  • Pramoxine HCL

NET WT. 0.5 oz ( 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
Principal Display Panel – Carton Label

POMADA DE LA CAMPANA

Originial Ointment 

First Aid Antibiotic + Pain Relief Ointment

NET WT. 0.5 oz ( 14g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)