Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID a0b3f819-fd71-451b-b497-bda5609cbfcb
Route
TOPICAL
Published
Effective Date 2015-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-08-27

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 the 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 the ingredients

Other Information
  • do not use if seal is punctured or damaged
  • store at room temperature

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin



Ask A Doctor Before Use
  • in case of deep or puncture wounds, animal bites or serious burns

Principal Display Panel

Bacitracin Zinc Ointment

first aid antibiotic

Cardinal Health

NDC 63517-220-02

Net Wt. 1.0 oz (28.3g)











When Using This Product

do not use longer than 1 week unless directed by a doctor



Stop Use and Ask A Doctor If

the condition persists or gets worse. If a rash or other allergenic reaction develops



Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away



Active Ingredient (in Each Gram)

Bacitracin Zinc (500 units)






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 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
  • over large areas of the body
  • if you are allergic to the ingredients

Other Information (Other information)
  • do not use if seal is punctured or damaged
  • store at room temperature

Inactive Ingredients (Inactive ingredients)

Hard Paraffin, Liquid Paraffin, White Soft Paraffin



Ask A Doctor Before Use (Ask a doctor before use)
  • in case of deep or puncture wounds, animal bites or serious burns

Principal Display Panel

Bacitracin Zinc Ointment

first aid antibiotic

Cardinal Health

NDC 63517-220-02

Net Wt. 1.0 oz (28.3g)











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)

the condition persists or gets worse. If a rash or other allergenic 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



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

Bacitracin Zinc (500 units)






Advanced Ingredient Data


Raw Label Data

All Sections (JSON)