Estriol Cream

Estriol Cream is an FDA-registered drug product whose active ingredient is ESTRIOL. It is labelled by Guangxi Keyun E-commerce Co., Ltd. taken by vaginal and marketed as a human otc drug product. Identifiers on file: NDC 87278-010, application M016, label effective 20260827. It is one of 4 FDA drug label records sharing the active ingredient ESTRIOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ESTRIOL are most often described in connection with: helps maintain, hormonal balance, help ease, symptoms associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Helps maintain hormonal balance. May help ease symptoms associated with menopause.

Take 2 pumps of this product onto your fingertips Apply cream evenly to the intimate area (inner labia and perineal region) Wait for 20 minutes until the cream is fully absorbed. Precautions Target audience: For adult women only.

For external use only

FDA lists 4 drug label records with ESTRIOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Estriol Cream used for?
Helps maintain hormonal balance. May help ease symptoms associated with menopause.

Who makes Estriol Cream?
Guangxi Keyun E-commerce Co., Ltd. is the labeler of record for Estriol Cream. 4 FDA label records share the active ingredient ESTRIOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Estriol Cream come in?
administered by vaginal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Estriol Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ESTRIOL?
Yes. 4 FDA drug label records list ESTRIOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Estriol Cream been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.