epic triple antibiotic

epic triple antibiotic
SPL v1
SPL
SPL Set ID fbbe6521-0e26-5372-e053-6394a90ae5e4
Route
topical
Published
Effective Date 2023-05-10
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
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2021-05-15

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic

Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin) Polymyxin B sulfate 5000 units


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 ■ 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 59-86F (15-30°C) ■ avoid excessive heat and humidity

Inactive Ingredients

White Petrolatum

Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin) Polymyxin B sulfate 5000 units

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

Package Label

Active Ingredients

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Stop Use and Consult A Doctor If

■ the condition persists or gets worse ■ a rash or other allergic reaction develops

Ask A Physician Before Use in Case Of

■ deep or puncture wounds ■ animal bites ■ serious burns


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 ■ 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 59-86F (15-30°C) ■ avoid excessive heat and humidity

Inactive Ingredients (Inactive ingredients)

White Petrolatum

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

Package Label

Active Ingredients (Active ingredients)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

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

■ the condition persists or gets worse ■ a rash or other allergic reaction develops

Ask A Physician Before Use in Case Of (Ask a physician before use in case of)

■ deep or puncture wounds ■ animal bites ■ serious burns


Advanced Ingredient Data


Raw Label Data

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