49314-0006, unishield antibiotic oniment

49314-0006, unishield antibiotic oniment
SPL v1
SPL
SPL Set ID 00b85d3a-322b-43c1-b022-5f6ed50c6609
Route
topical
Published
Effective Date 2024-03-02
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 2024-03-02
Purpose

First aid antibiotic First aid antibiotic 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

First aid antibiotic

First aid antibiotic

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.
Other Information

Store at room temperature

Tamper evident. Do not use if packet is torn out or opened.

Inactive Ingredients

Mineral oil, petrolatum, purified water

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 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.

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 immediately.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or 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

First aid antibiotic

First aid antibiotic

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.
Other Information

Store at room temperature

Tamper evident. Do not use if packet is torn out or opened.

Inactive Ingredients

Mineral oil, petrolatum, purified water

Section 51945-4 (51945-4)

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.

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 immediately.

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: 2026-02-15T12:02:49.835929 · Updated: 2026-03-14T23:02:36.495120