Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 8d19e931-99c4-47b8-b7ec-94c16535166f
Route
TOPICAL
Published
Effective Date 2013-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 U)
Inactive Ingredients
Paraffin Lanolin Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-02-05
Description

Bacitracin Zinc (equal to 500 Bacitracin units)

Purpose

Antibiotic

Medication Information

Purpose

Antibiotic

Description

Bacitracin Zinc (equal to 500 Bacitracin units)

Uses

First aid to prevent infection in Minor cuts, Scrapes & Burns

Warnings

For External Use Only.

Directions
  • Clean the affected area
  • Apply 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

Do Not Use
  • In the eyes
  • If you are allergic to any of the ingredients, due to possibility of anaphylactic shock

  • Over large areas of the body
  • Longer than 1 week unless directed by a doctor
  • Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

Other Information
  • Store at controlled room temperature 15 o- 30 oC(59 o--86 oF)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet is torn, cut, or opened.

Inactive Ingredients

Hard Paraffin, Lanolin, Liquid Paraffin,White Soft Paraffin

Principal Display Panel

Stop Use and Ask A Doctor If
  • The condition persists or gets worse
  • A rash or allergic reaction develops

Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Centre right away

Active Ingredients(in Each Gram)

Bacitracin Zinc (equal to 500 Bacitracin units)





Structured Label Content

Uses

First aid to prevent infection in Minor cuts, Scrapes & Burns

Purpose

Antibiotic

Warnings

For External Use Only.

Directions
  • Clean the affected area
  • Apply 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

Do Not Use (Do not use)
  • In the eyes
  • If you are allergic to any of the ingredients, due to possibility of anaphylactic shock

  • Over large areas of the body
  • Longer than 1 week unless directed by a doctor
  • Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

Other Information (Other information)
  • Store at controlled room temperature 15 o- 30 oC(59 o--86 oF)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet is torn, cut, or opened.

Inactive Ingredients

Hard Paraffin, Lanolin, Liquid Paraffin,White Soft Paraffin

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • The condition persists or gets worse
  • A rash or 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 Centre right away

Active Ingredients(in Each Gram) (Active Ingredients(in each gram))

Bacitracin Zinc (equal to 500 Bacitracin units)





Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.864551 · Updated: 2026-03-14T23:09:05.302478