Cuadriderma®

Cuadriderma®
SPL v10
SPL
SPL Set ID 4fa99b96-ab4b-4523-82bc-343dbaf39fb6
Route
TOPICAL
Published
Effective Date 2022-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-31

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

helps prevent infection in and temporarily relieves pain due to

  • *
    minor cuts
  • *
    scrapes
  • *
    burns
Section 42229-5

Drug Facts

Section 50565-1

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

Section 55105-1
Active ingredients (in each gram) Purpose
Bacitracin 500 units First aid antibiotic
Neomycin 3.5 mg First aid antibiotic
Polymyxin B 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg Pain reliever
Warnings

For external use only

Directions

Adults and children 2 years and older:

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

Children under 2 years: ask a doctor

Do Not Use
  • *
    in or near the eyes
  • *
    on large areas of the body
Allergy Alert
  • *
    do not use if allergic to any of the ingredients
Other Information

Store at controlled room temperature 68°-77°F (20°-25°C)

Questions Comments

1 (305) 653-2700

Inactive Ingredient

Petrolatum

When Using This Product
  • *
    do not use longer than 1 week
Stop Use and Ask A Doctor If
  • *
    condition lasts 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 occurs.
Ask A Doctor Before Use If You Have
  • *
    deep or puncture wounds
  • *
    animal bites
  • *
    serious burns
Principal Display Panel 28.35 G Tube Carton

Original

Cuadriderma ®

First Aid Antibiotic / Pain Relief Ointment

Net Wt. 1 oz (28.35 g.)

Pro-Mex®


Structured Label Content

Uses

helps prevent infection in and temporarily relieves pain due to

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

Drug Facts

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)
Active ingredients (in each gram) Purpose
Bacitracin 500 units First aid antibiotic
Neomycin 3.5 mg First aid antibiotic
Polymyxin B 10,000 units First aid antibiotic
Pramoxine hydrochloride 10 mg Pain reliever
Warnings

For external use only

Directions

Adults and children 2 years and older:

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

Children under 2 years: ask a doctor

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 allergic to any of the ingredients
Other Information (Other information)

Store at controlled room temperature 68°-77°F (20°-25°C)

Questions Comments

1 (305) 653-2700

Inactive Ingredient (Inactive ingredient)

Petrolatum

When Using This Product (When using this product)
  • *
    do not use longer than 1 week
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • *
    condition lasts 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 occurs.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • *
    deep or puncture wounds
  • *
    animal bites
  • *
    serious burns
Principal Display Panel 28.35 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton)

Original

Cuadriderma ®

First Aid Antibiotic / Pain Relief Ointment

Net Wt. 1 oz (28.35 g.)

Pro-Mex®


Advanced Ingredient Data


Raw Label Data

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