Astonea
FDA Label NDC 77338-302

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Astonea (NDC 77338-302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients(in each gram), purpose, uses, warnings, do not use, ask a physician before use in case of, stop use and consult a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients(In Each Gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Purpose

First Aid AntibioticFirst Aid AntibioticFirst Aid Antibiotic

Uses

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

Warnings

For external use only

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

Ask A Physician Before Use In Case Of

■ deep or puncture wounds ■ animal bites ■ serious burns

Stop Use And Consult A Doctor If

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

Otc - 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.

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

Inactive Ingredients

white petrolatum

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