71927-021-01 Orazen Triple Antibiotic Ointment

71927-021-01 Orazen Triple Antibiotic Ointment
SPL v1
SPL
SPL Set ID e6e5263b-328f-4775-9fac-34302f050ce0
Route
TOPICAL
Published
Effective Date 2023-10-18
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
Mineral Oil Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-18
Description

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

Purpose

first aid antibiotic

Medication Information

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)

Uses

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

Section 51945-4

Warnings

For external use only.

Directions
  • Clean and disinfect 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.
Do Not Use
  • in the 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
Other Information

Store at 20C to 25C (68 to 77F)

Do not use if tube seal under cap is broken or missing

Active Ingredients

(in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate（neomycin 3.5 mg）

Polymyxin B sulfate (polymyxin B 5,000 units)

Inactive Ingredients

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor 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, or serious burns

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose

first aid antibiotic

Warnings

For external use only.

Directions
  • Clean and disinfect 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.
Do Not Use (Do not use)
  • in the 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
Other Information

Store at 20C to 25C (68 to 77F)

Do not use if tube seal under cap is broken or missing

Active Ingredients

(in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate（neomycin 3.5 mg）

Polymyxin B sulfate (polymyxin B 5,000 units)

Inactive Ingredients

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor 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, or serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:28.338362 · Updated: 2026-03-14T23:01:25.991637