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

Description

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

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic


Medication Information

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

Uses

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

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

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

Other Information

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

Active Ingredients

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Inactive Ingredients

White Petrolatum

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

Uses

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Warnings

For external use only

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

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

Other Information

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

Active Ingredients (Active ingredients)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Inactive Ingredients (Inactive ingredients)

White Petrolatum

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

All Sections (JSON)