bacitracin zinc

bacitracin zinc
SPL v2
SPL
SPL Set ID 4594948d-1f25-4d3c-a615-9e6edda05a10
Route
topical
Published
Effective Date 2023-12-19
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 drug active Since 2023-12-15

Purpose

First aid antibiotic

Description

Drug Facts


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 and dry thoroughly
  • 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
Other Information
  • To open: unscrew cap, pull tab to remove foil seal
  • Store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

mineral oil, white petrolatum

Description

Drug Facts

Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Ask A Doctor Before Use
  • on deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If
  • condition persists or gets worse
  • a rash or other allergic reaction develops
Active Ingredient (each Gram Contains)

Bacitracin Zinc 500 units

Principal Display Panel 28.4 G Tube Carton

Foster & Thrive™

Antibiotic Ointment

Bacitracin Zinc

FIRST AID ANTIBIOTIC

NET WT 1 OZ (28.4 g)


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 and dry thoroughly
  • 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
Other Information (Other information)
  • To open: unscrew cap, pull tab to remove foil seal
  • Store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

mineral oil, white petrolatum

Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Ask A Doctor Before Use (Ask a doctor before use)
  • on deep or puncture wounds, animal bites, or serious burns
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
Active Ingredient (each Gram Contains) (Active ingredient (each gram contains))

Bacitracin Zinc 500 units

Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Foster & Thrive™

Antibiotic Ointment

Bacitracin Zinc

FIRST AID ANTIBIOTIC

NET WT 1 OZ (28.4 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)