Triple Antibiotic Plus Ointment

Triple Antibiotic Plus Ointment
SPL v5
SPL
SPL Set ID 69d911c2-cb89-2241-35f8-c83acfe18249
Route
TOPICAL
Published
Effective Date 2023-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1998-02-28

Description

Active ingredients (in each gram) Purpose  Bacitracin zinc 500 units  First aid antibiotic  Neomycin 3.5 mg  First aid antibiotic  Polymyxin B sulfate 10,000 units  First aid antibiotic  Pramoxine hydrochloride 10.0 mg  Topical analgesic


Medication Information

Description

Active ingredients (in each gram) Purpose  Bacitracin zinc 500 units  First aid antibiotic  Neomycin 3.5 mg  First aid antibiotic  Polymyxin B sulfate 10,000 units  First aid antibiotic  Pramoxine hydrochloride 10.0 mg  Topical analgesic

Uses

first aid to help prevent infection and provide temporary relief of pain or discomfort in minor • cuts • scrapes • burns

Section 55105-1
Active ingredients (in each gram) Purpose
 Bacitracin zinc 500 units  First aid antibiotic
 Neomycin 3.5 mg  First aid antibiotic
 Polymyxin B sulfate 10,000 units  First aid antibiotic
 Pramoxine hydrochloride 10.0 mg  Topical analgesic

Warnings

For external use only.

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • a rash or other allergic reaction develops
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 doctor

Other Information

store at room temperature

Inactive Ingredient

light mineral oil, white petrolatum

Principal Display Panel

Triple Antibiotic Plus Ointment

Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl

FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT

Net Wt. 1 oz

(28.4 g)

Keep Out of Reach of Children

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


Structured Label Content

Uses (USES)

first aid to help prevent infection and provide temporary relief of pain or discomfort in minor • cuts • scrapes • burns

Section 55105-1 (55105-1)
Active ingredients (in each gram) Purpose
 Bacitracin zinc 500 units  First aid antibiotic
 Neomycin 3.5 mg  First aid antibiotic
 Polymyxin B sulfate 10,000 units  First aid antibiotic
 Pramoxine hydrochloride 10.0 mg  Topical analgesic

Warnings (WARNINGS)

For external use only.

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • a rash or other allergic reaction develops
Directions (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 doctor

Other Information (OTHER INFORMATION)

store at room temperature

Inactive Ingredient (INACTIVE INGREDIENT)

light mineral oil, white petrolatum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Triple Antibiotic Plus Ointment

Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl

FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT

Net Wt. 1 oz

(28.4 g)

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.


Advanced Ingredient Data


Raw Label Data

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