drug facts

drug facts
SPL v1
SPL
SPL Set ID 35083d42-5823-eeb1-e063-6294a90acafa
Route
topical
Published
Effective Date 2025-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [USP'U]) neomycin (0.0035 g) polymyxin b (500 [USP'U])
Inactive Ingredients
white petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-13
Purpose

First Aid Antibiotic

Description

Bacitracin Zinc (400 units) Neomycin sulfate 5mg (equivalent to 3.5 mg Neomycin) Polymyxin B sulfate (500 units)

Medication Information

Warnings

For external use only.

Uses

First aid to prevent infection in

  • minor cuts
  • scrapes
  • 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 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
Inactive Ingredients

White soft paraffin

Description

Bacitracin Zinc (400 units) Neomycin sulfate 5mg (equivalent to 3.5 mg Neomycin) Polymyxin B sulfate (500 units)

Section 51945-4

NDC 68786-400-28

SionBiotext

Triple Antibiotic Ointment

First aid to prevent infection in Minor cuts | Scrapes | Burns

For Personal and Professional Use

Net. Wt: 1.0 oz (28.3g)

Questions

[email protected]

Do Not Use
  • in the eyes
  • over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns,
  • consult a doctor: if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
  • if the seal is torn or if the tube is damaged

Stop Use and Ask A Doctor If
  • if condition persists or gets worse
  • a rash or other allergic reaction develops
If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

If swalloed, get medical help or contact a poison control center right away

Active Ingredient (in Each Gram)

Bacitracin Zinc (400 units)

Neomycin sulfate 5mg (equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate (500 units)

Structured Label Content

Warnings

For external use only.

Uses

First aid to prevent infection in

  • minor cuts
  • scrapes
  • 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 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
Inactive Ingredients

White soft paraffin

Section 51945-4 (51945-4)

NDC 68786-400-28

SionBiotext

Triple Antibiotic Ointment

First aid to prevent infection in Minor cuts | Scrapes | Burns

For Personal and Professional Use

Net. Wt: 1.0 oz (28.3g)

Questions

[email protected]

Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns,
  • consult a doctor: if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
  • if the seal is torn or if the tube is damaged

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • if condition persists or gets worse
  • a rash or other allergic reaction develops
If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use

Keep Out of Reach of Children (keep out of reach of children)

If swalloed, get medical help or contact a poison control center right away

Active Ingredient (in Each Gram) (Active Ingredient (In Each Gram))

Bacitracin Zinc (400 units)

Neomycin sulfate 5mg (equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate (500 units)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:07.460955 · Updated: 2026-03-14T23:08:42.212838