Drug Facts

Drug Facts
SPL v14
SPL
SPL Set ID ea16e1de-0100-456b-abe6-d33de78221da
Route
TOPICAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U])
Inactive Ingredients
Paraffin Mineral Oil White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01
Description

Bacitracin Zinc

Medication Information

Warnings and Precautions

For external use only

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 unless directed by a doctor

Ask a doctor before use if you have:

  • animal bites
  • serious burns
  • deep or puncture wounds

Stop use and ask a doctor if

  • condition persists or gets worse
  • rash or other allergic reaction develops
Indications and Usage

 First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Dosage and Administration
  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage
Description

Bacitracin Zinc

Section 50565-1

Keep out of Reach of Children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Mineral Oil, Paraffin, White Petrolatum

Section 51945-4

Section 55105-1

First Aid Antibiotic

Section 55106-9

Bacitracin Zinc

Structured Label Content

Indications and Usage (34067-9)

 First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Dosage and Administration (34068-7)
  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage
Warnings and Precautions (34071-1)

For external use only

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 unless directed by a doctor

Ask a doctor before use if you have:

  • animal bites
  • serious burns
  • deep or puncture wounds

Stop use and ask a doctor if

  • condition persists or gets worse
  • rash or other allergic reaction develops
Section 50565-1 (50565-1)

Keep out of Reach of Children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Mineral Oil, Paraffin, White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

First Aid Antibiotic

Section 55106-9 (55106-9)

Bacitracin Zinc

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:26.632756 · Updated: 2026-03-14T23:10:53.901398