Astonea
FDA Label NDC 77338-304

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 77338-304). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

When Using This Product

■ do not get into eyes

■ do not use over large areas of the body

Stop Use And Ask A Doctor If

■ the condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days ■ if you are allergic to any of these ingredients

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

■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed

Other Information

■ store at 59-86F (15-30C)

* Please review the disclaimer below.