quality choice multi-action ointment

quality choice multi-action ointment
SPL v2
SPL
SPL Set ID eac8e7a8-4524-7377-e053-2a95a90a9a63
Route
topical
Published
Effective Date 2021-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
polymyxin b (10000 [USP'U]) bacitracin (500 [USP'U]) neomycin (3.5 mg) pramoxine (10 mg)
Inactive Ingredients
pyruvic acid alpha-tocopherol olive oil petrolatum levant cottonseed oil cocoa butter

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2022-08-30

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units


Medication Information

Warnings

For external use only. Do not use:

  • If you are allergic to any of the ingredients
  • in or near the eyes
  • on large areas of the body

Uses

Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.

Purpose

First Aid Antibiotic

Directions

Adults and children 2 years and older:

  • Clean the affected area
  • 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

Children under 2 years: ask a doctor

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
Description

Bacitracin Zinc 500 Units

Questions?

Call 1-800-935-2362

Packaging

Active Ingredient

Bacitracin Zinc 500 Units

Inactive Ingredient:

Cocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E

Ask A Doctor Before Use

Ask Doctor before use if you have:

  • Deep or puncture wounds
  • Animal bites
  • Serious burns
When Using This Product

Do not use longer than 1 week

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:
  • Condition lasts or gets worse
  • Symptoms last for more than 7 days or clear up and come back within a few days
  • A rash or other allergic reaction develops

Structured Label Content

Warnings

For external use only. Do not use:

  • If you are allergic to any of the ingredients
  • in or near the eyes
  • on large areas of the body

Uses

Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.

Purpose

First Aid Antibiotic

Directions

Adults and children 2 years and older:

  • Clean the affected area
  • 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

Children under 2 years: ask a doctor

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
Questions?

Call 1-800-935-2362

Packaging

Active Ingredient

Bacitracin Zinc 500 Units

Inactive Ingredient:

Cocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E

Ask A Doctor Before Use (Ask a Doctor before Use)

Ask Doctor before use if you have:

  • Deep or puncture wounds
  • Animal bites
  • Serious burns
When Using This Product (When using this product)

Do not use longer than 1 week

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

Stop Use and Ask A Doctor If: (Stop Use and ask a Doctor if:)
  • Condition lasts or gets worse
  • Symptoms last for more than 7 days or clear up and come back within a few days
  • A rash or other allergic reaction develops

Advanced Ingredient Data


Raw Label Data

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