astonea triple antibiotic

astonea triple antibiotic
SPL v3
SPL
SPL Set ID de0982e3-37ab-a829-e053-2995a90a53e8
Route
topical
Published
Effective Date 2013-05-22
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 drug active Since 2022-05-02

Purpose

First Aid AntibioticFirst Aid AntibioticFirst 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 AntibioticFirst Aid AntibioticFirst 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 15-30C (59-86F) ■ avoid excessive heat and humidity■Tamper evident■Do not use if packet is cut, torn or opened

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 AntibioticFirst Aid AntibioticFirst 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 15-30C (59-86F) ■ avoid excessive heat and humidity■Tamper evident■Do not use if packet is cut, torn or opened

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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