Major Bacitracin Ointment

Major Bacitracin Ointment
SPL v7
SPL
SPL Set ID a23ce772-7078-0a4b-e053-2995a90aff0d
Route
TOPICAL
Published
Effective Date 2020-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Bacitracin Zinc 500 Units per gram

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units per gram

Uses

First Aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Warnings

For External Use Only.

Packaging

Questions

Call 1-800-616-2471

Directions
  • Clean the affected area
  • Apply a small amount of the 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 eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients, due to the possiblity of anaphylactic shock
  • longer than 1 week unless directed by a doctor
Active Ingredient

Bacitracin Zinc 500 Units per gram

Other Information

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

Storage Information

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

Inactive Ingredients

mineral oil, white petrolatum

Ask Doctor Before Use

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor If
  • Before use in case of deep puncture wounds, animal bites or serious burns
  • The condition persists or gets worse
  • A rash or allergic reaction develops
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Uses

First Aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Purpose

First Aid Antibiotic

Warnings

For External Use Only.

Packaging

Questions

Call 1-800-616-2471

Directions
  • Clean the affected area
  • Apply a small amount of the 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 eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients, due to the possiblity of anaphylactic shock
  • longer than 1 week unless directed by a doctor
Active Ingredient

Bacitracin Zinc 500 Units per gram

Other Information

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

Storage Information

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

Inactive Ingredients

mineral oil, white petrolatum

Ask Doctor Before Use (Ask Doctor before Use)

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor If (Stop Use and Ask Doctor if)
  • Before use in case of deep puncture wounds, animal bites or serious burns
  • The condition persists or gets worse
  • A rash or 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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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