Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f1f7ba23-6a90-4eaa-8eeb-d73db774b863
Route
TOPICAL
Published
Effective Date 2013-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-02

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

Warnings

For external use only

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
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Package Label

Other Information

store at 20 - 25C (68 - 77F)

Inactive Ingredients

light mineral oil, white petrolatum

When Using This Product
  • do not use longer than 1 week unless directed by a doctor
Stop Use and Ask A Doctor If
  • condition persists or gets worse
  • a rash or other allergic reaction develops
Keep Out of Reach of Children

In case of accidental Ingestion, seek professional assistance or contact a Poison Control Center immediately.

Active Ingredient (in Each Gram)

Bacitracin Zinc 500 units

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites

Structured Label Content

Uses

 First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Purpose

First aid antibiotic

Warnings

For external use only

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
  • over large areas of the body
  • if you are allergic to any of the ingredients
Package Label (Package label)

Other Information (Other information)

store at 20 - 25C (68 - 77F)

Inactive Ingredients (Inactive ingredients)

light mineral oil, white petrolatum

When Using This Product (When using this product)
  • do not use longer than 1 week unless directed by a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition persists or gets worse
  • a rash or other allergic reaction develops
Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental Ingestion, seek professional assistance or contact a Poison Control Center immediately.

Active Ingredient (in Each Gram) (Active ingredient (in each gram))

Bacitracin Zinc 500 units

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)