drug facts

drug facts
SPL v1
SPL
SPL Set ID 3758e221-df99-48b5-81e5-e9adaaba592f
Route
topical
Published
Effective Date 2012-07-16
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
cetyl alcohol glycerin light mineral oil steareth-2 squalane stearic acid .alpha.-tocopherol acetate, d- petrolatum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-07-16
Purpose

First aid antibiotic First aid antibiotic First aid antibiotic

Description

Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units

Medication Information

Warnings
For external use only



Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Directions
  • adults and children 2 years of age or 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

Other Information

  • store at 59 ° to 77 ° F

Inactive Ingredients

Cetyl alcohol, Glycerin, Light mineral oil, Steareth-2, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

Description

Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units

Do Not Use

if you are allergic to any of the ingredients

Active Ingredients

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Package Label Panel

Triple Antibiotic Ointment

When Using This Product
  • do not use in the eyes
  • do not apply over large areas of the body

Stop Use and Ask A Doctor If
  • you need to use more 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

Keep Out of Reach of Children.

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

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

Structured Label Content

Warnings
For external use only



Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Directions
  • adults and children 2 years of age or 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

Other Information (Other information)

  • store at 59 ° to 77 ° F

Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, Glycerin, Light mineral oil, Steareth-2, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

Do Not Use (Do not use)

if you are allergic to any of the ingredients

Active Ingredients (Active ingredients)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Package Label Panel (Package label panel)

Triple Antibiotic Ointment

When Using This Product (When using this product)
  • do not use in the eyes
  • do not apply over large areas of the body

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use more 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

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.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.850163 · Updated: 2026-03-14T22:53:14.066899