Triple Antibiotic Ointment 

Triple Antibiotic Ointment 
SPL v3
SPL
SPL Set ID 844cd9a1-b68e-47d8-a5eb-c9e880ba019e
Route
TOPICAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01

Description

Drug Facts

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Drug Facts

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
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.

Section 51945-4

Principal Display Panel – Carton Label

Leader  NDC 70000-0094-1

Triple Antibiotic Ointment USP

  • Bacitracin Zinc 
  • Neomycin Sulfate
  • Polymyxin B Sulfate

First Aid Antibiotic Ointment

NET WT.  0.5oz (14g)

Warnings

For external use only

Directions
  • 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
Do Not Use
  • in or near the eyes
  • on large areas of the body
Allergy Alert:
  • do not use if you are allergic to any of the ingredients
Other Information
  • Store at a controlled room temperature 20º-25ºC (68° to 77°F)
Inactive Ingredient

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 400 Units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 5,000 units

Consult A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns

Structured Label Content

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
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.

Section 51945-4 (51945-4)

Principal Display Panel – Carton Label

Leader  NDC 70000-0094-1

Triple Antibiotic Ointment USP

  • Bacitracin Zinc 
  • Neomycin Sulfate
  • Polymyxin B Sulfate

First Aid Antibiotic Ointment

NET WT.  0.5oz (14g)

Purpose

First aid antibiotic

Warnings

For external use only

Directions
  • 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
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 you are allergic to any of the ingredients
Other Information (Other information)
  • Store at a controlled room temperature 20º-25ºC (68° to 77°F)
Inactive Ingredient (Inactive ingredient)

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 400 Units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 5,000 units

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)