Triple Antibiotic Plus Pain Relief

Triple Antibiotic Plus Pain Relief
SPL v5
SPL
SPL Set ID 506fcda5-df44-49c8-8dbd-cab7434b06b2
Route
TOPICAL
Published
Effective Date 2023-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-21

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

first aid to help prevent infection and for the temporary relief of pain in 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 right away.

Section 55105-1
Active ingredients (in each gram) Purpose
Bacitracin zinc 500 units First aid antibiotic
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine HCl 10 mg External analgesic
Warnings

For external use only.

Directions
  • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor
Do Not Use
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions?

Call toll free 1-877-994-3666Monday to Friday 8am to 6pm, Central time

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • to open: unscrew cap, pull tab to remove foil seal
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient

white petrolatum

Stop Use and Ask A Doctor If
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel 28.4 G Tube Carton

cicatricure ®

OPEN WOUND

FOR MINOR CUTS, SCRAPES AND BURNS

PAIN, ITCH & SCAR

  • Triple Antibiotic Ointment
  • Up to 24-Hour Infection Protection
  • Maximum Strength: Infection Protection,

    Pain & Itch Relief
  • Helps Healing Wounds, Minimizing

    the Appearance of Scars**

FIRST AID ANTIBIOTIC

PAIN RELIEVING OINTMENT

Bacitracin Zinc – Neomycin Sulfate – Polyximin B Sulfate – Pramoxine HCl

*Based on published studies. For best results use sterile bandage or gauze.

**Preventing infection helps minimize appearance of scars.

NET WT.

1 oz (28.4 g)


Structured Label Content

Uses

first aid to help prevent infection and for the temporary relief of pain in 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 right away.

Section 55105-1 (55105-1)
Active ingredients (in each gram) Purpose
Bacitracin zinc 500 units First aid antibiotic
Neomycin sulfate 3.5 mg First aid antibiotic
Polymyxin B sulfate 10,000 units First aid antibiotic
Pramoxine HCl 10 mg External analgesic
Warnings

For external use only.

Directions
  • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor
Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions?

Call toll free 1-877-994-3666Monday to Friday 8am to 6pm, Central time

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
  • to open: unscrew cap, pull tab to remove foil seal
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredient (Inactive ingredient)

white petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops
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 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

cicatricure ®

OPEN WOUND

FOR MINOR CUTS, SCRAPES AND BURNS

PAIN, ITCH & SCAR

  • Triple Antibiotic Ointment
  • Up to 24-Hour Infection Protection
  • Maximum Strength: Infection Protection,

    Pain & Itch Relief
  • Helps Healing Wounds, Minimizing

    the Appearance of Scars**

FIRST AID ANTIBIOTIC

PAIN RELIEVING OINTMENT

Bacitracin Zinc – Neomycin Sulfate – Polyximin B Sulfate – Pramoxine HCl

*Based on published studies. For best results use sterile bandage or gauze.

**Preventing infection helps minimize appearance of scars.

NET WT.

1 oz (28.4 g)


Advanced Ingredient Data


Raw Label Data

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