SPL v2
SPL
SPL Set ID 36da7993-7c65-7430-e063-6294a90a0626
Route
TOPICAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [iU])
Inactive Ingredients
Paraffin White Petrolatum Mineral Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-05

Description

Bacitracin Zinc 500 units

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 units

Uses

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

Section 51945-4

Warnings

For External Use Only

Directions

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
Do Not Use

Do not use

  • In the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
  • longer than 1 week unles directed by a doctor
Active Ingredient

Bacitracin Zinc 500 units

Inactive Ingredients

Inactive Ingredients: Mineral Oil, Paraffin, White Petrolatum

Ask A Doctor Before Use

Ask a doctor before use if you have:

  • animal bites
  • serious burns
  • deep or puncture wounds
Stop Use and Ask A Doctor

Stop use and ask a doctor if

  • condition persists or gets worse
  • 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


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose

First Aid Antibiotic

Warnings

For External Use Only

Directions

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
Do Not Use

Do not use

  • In the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
  • longer than 1 week unles directed by a doctor
Active Ingredient

Bacitracin Zinc 500 units

Inactive Ingredients

Inactive Ingredients: Mineral Oil, Paraffin, White Petrolatum

Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if you have:

  • animal bites
  • serious burns
  • deep or puncture wounds
Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if

  • condition persists or gets worse
  • rash or other allergic reaction develops
Keep Out of Reach of Children (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


Advanced Ingredient Data


Raw Label Data

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