Estriol / Estradiol Cream is a compounded prescription medication that should only be used under the supervision of a licensed healthcare provider.

Important Notice About Compounded Medications

Compounded Estriol / Estradiol Cream is not FDA-approved. Compounded medications are prepared by licensed pharmacies for individual patient needs and are not reviewed by the FDA for safety, effectiveness, or quality before dispensing.

Important Safety Warning

Estrogen-containing therapies may increase the risk of:

• Blood clots
• Stroke
• Heart attack
• Endometrial cancer in women with a uterus
• Certain hormone-sensitive cancers
• Dementia in certain postmenopausal women

Hormone therapy should be used at the lowest effective dose and for the shortest duration consistent with treatment goals.

Do Not Use Estriol / Estradiol Cream If You:

• Have abnormal or unexplained vaginal bleeding
• Have a history of breast cancer or estrogen-dependent cancer unless specifically approved by your healthcare provider
• Have active or past blood clots, deep vein thrombosis (DVT), or pulmonary embolism
• Have had a stroke or heart attack
• Have liver disease
• Are pregnant or may become pregnant
• Have a known allergy to estriol, estradiol, or any ingredient in the formulation

Before Using Estriol / Estradiol Cream

Tell your healthcare provider if you:

• Have high blood pressure
• Have heart disease
• Have diabetes
• Have elevated cholesterol or triglycerides
• Have a history of migraines
• Have asthma
• Have epilepsy or seizure disorders
• Have lupus
• Have thyroid disorders
• Have endometriosis
• Have uterine fibroids
• Smoke or use tobacco products
• Are taking prescription medications, supplements, or hormone therapies

Common Side Effects

Possible side effects may include:

• Breast tenderness or breast pain
• Headache
• Nausea
• Abdominal bloating
• Fluid retention
• Mood changes
• Vaginal irritation, itching, or discharge
• Application-site irritation or redness

Serious Side Effects

Seek medical attention immediately if you experience:

• Unusual vaginal bleeding
• Signs of a blood clot, including leg pain, swelling, chest pain, or shortness of breath
• Signs of a stroke, including weakness on one side of the body or difficulty speaking
• Sudden vision changes or vision loss
• Severe headache
• Yellowing of the skin or eyes (possible liver problems)
• Signs of a serious allergic reaction, including rash, swelling, or difficulty breathing

Additional Safety Information

• Use exactly as prescribed by your healthcare provider.
• Apply only as directed and do not exceed the prescribed dosage.
• Wash hands after application.
• Avoid contact with the eyes and other sensitive areas.
• Attend recommended follow-up appointments and laboratory monitoring.
• Perform regular breast self-examinations and follow recommended mammogram schedules.
• Inform all healthcare providers that you are using hormone therapy.
• Keep out of reach of children.

Disclaimer

Results vary by individual. Compounded Estriol / Estradiol Cream is prescribed only after evaluation by a licensed healthcare provider. This information does not replace professional medical advice. Consult your healthcare provider regarding the risks, benefits, and whether this treatment is appropriate for you.