Astonea Cream
FDA Label NDC 77338-305

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 77338-305). 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, do not use, ask a doctor before use, stop use and ask 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.

Purpose

Anti-itch

Uses

■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

Ask A Doctor Before Use

■ if you are pregnant or breast feeding

Stop Use And Ask A Doctor If

■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days

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

Other Information

■ store at 20-25C (68-77F) 

■ avoid excessive heat and humidity

* Please review the disclaimer below.