SPL v4
SPL
SPL Set ID 485a779c-017b-4064-a446-e5073c1bdb07
Route
TOPICAL
Published
Effective Date 2023-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-01-23
Description

Drug Facts

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic Pain reliever

Medication Information

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Description

Drug Facts

Uses

helps prevent infection in and temporarily relieves pain due to:

  • 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

Dr. Sheffield's NDC 11527-161-55

Triple Antibiotic Plus Pain Relief 

Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate •  Pramoxine HCL             

First Aid Antibiotic  Plus Pain Relieving Ointment

NET WT. 1 OZ (28 g)

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 68º-77ºF (20º-25ºC)
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 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg

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

Structured Label Content

Uses

helps prevent infection in and temporarily relieves pain due to:

  • 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

Dr. Sheffield's NDC 11527-161-55

Triple Antibiotic Plus Pain Relief 

Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate •  Pramoxine HCL             

First Aid Antibiotic  Plus Pain Relieving Ointment

NET WT. 1 OZ (28 g)

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

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 68º-77ºF (20º-25ºC)
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 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg

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)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:22.553638 · Updated: 2026-03-14T23:01:53.224533