Active Ingredient (In Each Gram)
Bacitracin Zinc (equal to 500 bacitracin units)
Astonea Ointment
FDA Label NDC 77338-303
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 77338-303). 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 ingredient (in each gram), purpose, uses, warnings, do not use, ask a doctor before use in case of, stop use and ask a doctor if, 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
Purpose
First Aid Antibiotic
Uses
■ first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns
Warnings
For external use only
Do Not Use
■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients, due to possibility of anaphylactic shock ■ over large areas of the body ■ longer than 1 week unless directed by a doctor
Ask A Doctor Before Use In Case Of
■ deep or puncture wounds
■ animal bites ■ serious burns
Stop Use And Ask A Doctor If
■ the condition persists or gets worse
■ a rash or other allergic reaction develops
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
Other Information
■ store at room temperature 15-30C (59-86F)
■ avoid excessive heat and humidity
Inactive Ingredients
hard paraffin, liquid paraffin, white soft paraffin, lanolin
* Please review the disclaimer below.
