Bacitracin Zinc Ointment, Usp

Bacitracin Zinc Ointment, Usp
SPL v1
SPL
SPL Set ID aee808f9-e759-4129-9661-29c2a3bd9a30
Route
TOPICAL
Published
Effective Date 2012-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2002-03-01

Description

(in each gram) Bacitracin zinc, USP 500 units

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

(in each gram) Bacitracin zinc, USP 500 units

Uses

Helps prevent infection in

  • minor cuts
  • scrapes
  • burns
Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients
Directions
  • clean affected area
  • apply a small 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
Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Active Ingredient

(in each gram)

Bacitracin zinc, USP 500 units

Other Information
  • Store at room temperature 59°-77°F (15°-25°C).
Inactive Ingredient

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

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

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label.principal Display Panel

Repackaged By:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

NDC 33261-707-01

Bacitracin Zinc Ointment, USP

First Aid Antibiotic Ointment

Net WT 1 OZ (28 g)

11051210E1                VC110188

Image Label

Structured Label Content

Uses (USES)

Helps prevent infection in

  • minor cuts
  • scrapes
  • burns
Purpose (PURPOSE)

First aid antibiotic

Warnings (WARNINGS)

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients
Directions (DIRECTIONS)
  • clean affected area
  • apply a small 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
Questions? (QUESTIONS?)

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Active Ingredient (ACTIVE INGREDIENT)

(in each gram)

Bacitracin zinc, USP 500 units

Other Information (OTHER INFORMATION)
  • Store at room temperature 59°-77°F (15°-25°C).
Inactive Ingredient (INACTIVE INGREDIENT)

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)

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

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Repackaged By:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

NDC 33261-707-01

Bacitracin Zinc Ointment, USP

First Aid Antibiotic Ointment

Net WT 1 OZ (28 g)

11051210E1                VC110188

Image Label

Advanced Ingredient Data


Raw Label Data

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