drug facts

drug facts
SPL v3
SPL
SPL Set ID dfefde48-99ca-4443-b0bc-73e6c095210e
Route
topical
Published
Effective Date 2014-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [USP'U]) neomycin (3.5 mg) polymyxin b (5000 [USP'U])
Inactive Ingredients
methylparaben mineral oil ceresin petrolatum propanediol propylparaben

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-06-15

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic

Description

Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B sulfate 5000U


Medication Information

Warnings

For external use only

Uses

first aid to help prevent infection in:  ■ minor cuts ■ scrapes ■ burns

Purpose

First Aid Antibiotic

First Aid Antibiotic

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

■ store at room temperature 68 to 77F (20to 25C) ■ see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

Description

Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B sulfate 5000U

Do Not Use

■ in the eyes ■ if you are allergic to any of the ingredients ■ longer than 1 week unless directed by a doctor ■ over large areas of the body

Package Label

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B sulfate 5000U

Ask A doctor Before Use

■ on deep puncture wounds, animal bites, or serious burns

Keep Out of Reach of Children

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

Stop Use and Consult A Doctor If

■ the condition persists worsens ■ a rash or other allergic reaction develops


Structured Label Content

Warnings

For external use only

Uses

first aid to help prevent infection in:  ■ minor cuts ■ scrapes ■ burns

Purpose

First Aid Antibiotic

First Aid Antibiotic

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

■ store at room temperature 68 to 77F (20to 25C) ■ see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

Do Not Use (Do not use)

■ in the eyes ■ if you are allergic to any of the ingredients ■ longer than 1 week unless directed by a doctor ■ over large areas of the body

Package Label

Active Ingredients (Active ingredients)

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B sulfate 5000U

Ask A doctor Before Use (Ask a doctor before use)

■ on deep puncture wounds, animal bites, or serious burns

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 Consult A Doctor If (Stop use and consult a doctor if)

■ the condition persists worsens ■ a rash or other allergic reaction develops


Advanced Ingredient Data


Raw Label Data

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