SPL v3
SPL
SPL Set ID 4c60b0a2-2f6f-4ded-9d6f-96fb1f40bbd4
Route
TOPICAL
Published
Effective Date 2017-08-08
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 Completed Since 2017-04-28 Until 2025-10-18
Description

Drug Facts

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic Pain Relief 

Medication Information

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain Relief 

Description

Drug Facts

Uses

helps prevent infection in and temporarily relieves pain due to 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.

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 HCL 10 mg 

Consult A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel – Carton Label

CVS Health NDC 69842-161-10

Triple Antibiotic & Pain Relief Ointment 

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

First Aid Antibiotic /Pain relieving Ointment

24 packets 

NET WT. 0.72 oz. (20.4g)

First Aid Treatment for Minor Cuts, Scrapes and Burns

Principal Display Panel – Packet Label

CVS Health  NDC 69842-161-10

Triple Antibiotic Ointment & Pain Relief Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate• Pramoxine HCL 

First Aid Antibiotic/Pain relieving Ointment 

NET WT. 0.03 oz. (0.9g)

Structured Label Content

Uses

helps prevent infection in and temporarily relieves pain due to 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.

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain Relief 

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 HCL 10 mg 

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

CVS Health NDC 69842-161-10

Triple Antibiotic & Pain Relief Ointment 

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

First Aid Antibiotic /Pain relieving Ointment

24 packets 

NET WT. 0.72 oz. (20.4g)

First Aid Treatment for Minor Cuts, Scrapes and Burns

Principal Display Panel – Packet Label

CVS Health  NDC 69842-161-10

Triple Antibiotic Ointment & Pain Relief Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate• Pramoxine HCL 

First Aid Antibiotic/Pain relieving Ointment 

NET WT. 0.03 oz. (0.9g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:22.629253 · Updated: 2026-03-14T23:05:04.083969