Compounded Estriol / Niacinamide / GHK-Cu / Hyaluronic Acid Cream

Important Safety Information — For External Skin Use

Prescription and FDA information

This is a compounded prescription medication containing estriol, an estrogen hormone. Compounded medications are not FDA-approved. FDA does not evaluate their safety, effectiveness, or quality before they are marketed. Your clinician should determine whether this formulation is appropriate for your individual medical needs. FDA compounding information

There are no FDA-approved drugs containing estriol. FDA has not established that estriol-containing drugs are safe and effective or that estriol is a safer form of estrogen. Descriptions such as “natural” or “bioidentical” do not establish greater safety. FDA estriol information

The safety, effectiveness, systemic absorption, and long-term effects of this particular combination have not been established. Research on individual ingredients or other formulations does not establish the same results for your prescribed cream.

How the ingredients work

• Estriol interacts with estrogen receptors. Topical estrogens have been studied for effects on skin structure and appearance, but clinical evidence for visible improvements is limited and inconsistent. Long-term safety for facial/body skin-care use remains insufficiently established. Estriol receptor research, Topical estrogen review

• Niacinamide, a form of vitamin B3, can support skin-barrier lipids and reduce moisture loss. Certain studied formulations have also improved the appearance of uneven pigmentation. These findings do not establish the effectiveness of this compounded combination. Barrier study, Pigmentation study

• GHK-Cu, also called copper tripeptide, is a copper-binding peptide studied for effects on skin cells and extracellular-matrix proteins. Laboratory findings do not establish that this cream regenerates tissue, heals wounds, or produces clinically meaningful collagen changes. Laboratory research

• Hyaluronic acid binds water and can help moisturize the skin. Its effects depend on the concentration, molecular weight, and formulation. Topical hyaluronic acid study

Estriol and possible systemic effects

Do not assume that a skin-applied estrogen remains entirely within the skin. Absorption and hormonal effects can vary with the formulation, amount applied, treatment area, application site, and skin condition. Studies of topical estrogens have observed systemic absorption or hormonal activity in some settings. Topical estrogen review

Systemic estrogen exposure can raise concerns about blood clots, stroke, and stimulation of estrogen-sensitive tissues. In patients with a uterus, prolonged systemic estrogen exposure without appropriate endometrial protection can increase the risk of endometrial hyperplasia and cancer. The extent of these risks with this particular cream is unknown. These are estrogen-class precautions, rather than measured risk estimates for this formulation. Estrogen prescribing information

Tell your clinician whether you have a uterus and whether you use other hormones. Your clinician should assess your total estrogen exposure and whether additional precautions or endometrial protection are needed. Do not independently add or change hormone treatment.

Who should avoid treatment?

Because this cream contains estrogen, your prescriber should screen for estrogen-related contraindications. Do not use it if you have:

• Unexplained vaginal bleeding.

• Known, suspected, or previous breast cancer, or another estrogen-dependent cancer.

• Current or previous blood clots, stroke, or heart attack.

• A known thrombophilic disorder or significant liver disease.

• An allergy to estriol or another ingredient in the formulation.

These precautions are informed by approved estrogen labeling; this compounded cream has no FDA-approved prescribing information. Estrogen contraindications

Do not use this skin-care treatment during pregnancy, while trying to become pregnant, or while breastfeeding. If pregnancy occurs or is suspected, stop use and contact your clinician. This product should not be used by children.

Possible side effects and when to seek care

Possible local reactions include burning, stinging, itching, redness, rash, or irritation. Reactions may be caused by an active ingredient, preservative, fragrance, or cream base. Reliable side-effect frequencies for this combination are not available.

If meaningful estrogen absorption occurs, possible effects include breast tenderness, headache, nausea, fluid retention, or vaginal spotting. These effects are described with other estrogen products and have not been quantified for this cream. Topical estrogen drug information

Stop use and seek emergency care for:

• Chest pain, sudden shortness of breath, or coughing blood.

• Sudden weakness, difficulty speaking, or loss of vision.

• Swelling of the lips, tongue, or throat, or difficulty breathing.

Obtain prompt medical evaluation for a painful, swollen leg, new breast lump, severe skin reaction, or unexplained vaginal bleeding. Any bleeding after menopause requires evaluation. Estrogen safety information

Safe use and precautions

Use only the amount, frequency, and application sites prescribed. Do not increase the treatment area or use extra cream to accelerate results.

For external facial/body skin use only. Avoid the eyes, mouth, and mucous membranes. Do not apply vaginally, to the breasts or nipples, or to broken, infected, or significantly irritated skin.

Do not use under an occlusive dressing or immediately after microneedling, laser treatment, or a chemical peel without specific clinician guidance. These circumstances require separate assessment of skin integrity and exposure.

Wash your hands after application. Prevent other people, especially children and pregnant individuals, from contacting the cream or treated skin. Follow the pharmacy’s instructions for drying, washing, and preventing transfer. Topical estrogen handling precautions

Tell your clinician about all medicines, supplements, hormone therapies, and skin-care treatments you use. Review other topical products before combining them, particularly if they cause irritation.

Follow the pharmacy’s storage instructions and beyond-use date. Keep the container closed and out of reach of children and pets. Do not share your prescription.

This information does not include every possible risk or interaction. Contact your prescriber or pharmacist with questions. Suspected adverse reactions or product-quality problems may also be reported to FDA MedWatch.