5f1491f0-abea-4852-93f3-d5b22c3c5a94

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

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic Pain reliever

Description

Drug Facts


Medication Information

Warnings

For external use only

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

Uses

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

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

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

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 or nose
  • on large areas of the body
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

Warnings

For external use only

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

Uses

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

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

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

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 or nose
  • on large areas of the body
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)