best choice triple antibiotic ointment plus pain relief

best choice triple antibiotic ointment plus pain relief
SPL v4
SPL
SPL Set ID d405fe06-7406-43b5-996b-caad16114171
Route
topical
Published
Effective Date 2012-09-05
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 final active Since 2012-09-05

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic

Description

Bacitracin Zinc 500 units Neomycin 3.5mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg


Medication Information

Warnings

For external use only

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

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: consult a physician
Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

petrolatum

Description

Bacitracin Zinc 500 units Neomycin 3.5mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg

Principal Display Panel

Best Choice Antibiotic Ointment Plus Pain Relief

Do Not Use
  • if you are allergic to any of the ingredients

  • in the eyes
  • over large areas of the body
Stop Use and Ask A Doctor If
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persists for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram)

Bacitracin Zinc 500 units



Neomycin 3.5mg



Polymyxin B Sulfate 10,000 units



Pramoxine HCl 10mg

Ask 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 and provide temporary relief of pain or discomfort in minor

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

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: consult a physician
Other Information (Other information)

store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

petrolatum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Best Choice Antibiotic Ointment Plus Pain Relief

Do Not Use (Do not use)
  • if you are allergic to any of the ingredients

  • in the eyes
  • over large areas of the body
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 persists for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin Zinc 500 units



Neomycin 3.5mg



Polymyxin B Sulfate 10,000 units



Pramoxine HCl 10mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)