43473-050, health&beyond, triple antibiotic ointment

43473-050, health&beyond, triple antibiotic ointment
SPL v3
SPL
SPL Set ID 0070ea5f-434d-53a7-e063-6294a90abf18
Route
topical
Published
Effective Date 2025-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [USP'U]) neomycin (0.0035 g) polymyxin b (5000 [USP'U])
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-07-27

Purpose

first aid antibiotic

Description

(in each gram) Bacitracin zinc (bacitracin 400 units) Neomycin sulfate(neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)


Medication Information

Warnings

For external use only.

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Purpose

first aid

antibiotic

Directions
  • 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.

Other Information

Store at room temperature

Inactive Ingredients

White petrolatum

Description

(in each gram) Bacitracin zinc (bacitracin 400 units) Neomycin sulfate(neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Section 51945-4

Do Not Use
  • in eyes 
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Active Ingredients

(in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate(neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Stop Use and Ask A Doctor If
  • if the condition persists or gets worse
  • a 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
  • deep or puncture wounds
  • animal bites
  • serious burns

Structured Label Content

Warnings

For external use only.

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Purpose

first aid

antibiotic

Directions
  • 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.

Other Information

Store at room temperature

Inactive Ingredients

White petrolatum

Section 51945-4 (51945-4)

Do Not Use (Do not use)
  • in eyes 
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Active Ingredients

(in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate(neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • if the condition persists or gets worse
  • a 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)
  • deep or puncture wounds
  • animal bites
  • serious burns

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)