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

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc (500 units)


Medication Information

Warnings

For external use only.

Uses

First aid to help prevent infection in





  • Minor cuts
  • Scrapes
  • Burns

Purpose

First Aid Antibiotic



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

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

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin



Description

Bacitracin Zinc (500 units)

Principal Display Panel

Bacitracin Zinc Ointment

first aid antibiotic

Cardinal Health

NDC 63517-220-02

Net Wt. 1.0 oz (28.3g)











Do Not Use
  • in the eyes
  • over large areas of the body
  • if you are allergic to the ingredients

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

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

Warnings

For external use only.

Uses

First aid to help prevent infection in





  • Minor cuts
  • Scrapes
  • Burns

Purpose

First Aid Antibiotic



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

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



Principal Display Panel

Bacitracin Zinc Ointment

first aid antibiotic

Cardinal Health

NDC 63517-220-02

Net Wt. 1.0 oz (28.3g)











Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • if you are allergic to the ingredients

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

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)