what-to-know-about

What to Know About EstraBalance Cream

EstraBalance Cream is the name Voshell’s Pharmacy uses for a compounded topical estradiol preparation. Educational information about its use and prescription requirements.

Not medical advice. Speak with a healthcare professional before using any medication.

Reviewed by:

D. Goren

Head of Content

Updated Nov, 30

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Disclaimer: This content is for informational purposes only and is not medical advice. Voshell's Pharmacy does not diagnose conditions or determine treatment plans. Patients should consult their licensed prescriber regarding therapy decisions. Compounded medications are not FDA-approved and prepared only pursuant to a valid prescription.

What Is EstraBalance Cream

DISCLOSURE: Voshell’s Pharmacy is a licensed compounding pharmacy that prepares and sells compounded medications by prescription. As a provider of competing products, our perspective may be influenced by our professional and commercial interests.

 

EstraBalance Cream is the name Voshell’s Pharmacy uses for compounded preparations that may include estradiol in a topical cream base, prepared in response to a valid prescription from a qualified prescriber. Compounded medications are not reviewed by FDA for safety or effectiveness before dispensing and are prepared by a licensed pharmacist only in response to a valid prescription for an individual patient.

 

Details — What It Contains and How It Is Described

 

What it contains: a compounded form of estradiol in a cream base formulated for vaginal or skin application. How it is described: according to the FDA-approved prescribing information for certain commercial vaginal estradiol products, estradiol is absorbed locally, and low-dose topical application may help restore vaginal tissue health and reduce dryness, itching, and urinary irritation with limited systemic absorption when used as directed. That prescribing information applies to FDA-reviewed commercial products; compounded EstraBalance Cream is not reviewed by FDA and those outcomes are not established for this compounded preparation. Voshell’s Pharmacy may prepare this preparation in varying strengths and bases to meet individual patient needs as prescribed.

 

Use, Benefits, and Safety Considerations

 

  • Use: applied as a qualified prescriber directs; wash hands after application and avoid contact with the breasts.
  • Benefits (commercial products): according to the North American Menopause Society (NAMS), low-dose topical estradiol may improve vaginal lubrication, tissue elasticity, and discomfort with intercourse, and may ease associated urinary symptoms. These findings relate to FDA-reviewed estradiol products; compounded preparations are not reviewed by FDA and clinical benefit is not established for this compounded preparation.
  • Safety: according to the FDA-approved prescribing information for systemic estrogens, estrogen-containing preparations are not appropriate for those with active breast cancer, uncontrolled thromboembolic disorders, or during pregnancy; the lowest effective dose should be used with regular follow-up by a qualified prescriber.
  • FDA boxed warnings: according to the FDA-approved prescribing information for systemic estrogens, products in this class carry boxed warnings regarding endometrial cancer (in unopposed-estrogen use), cardiovascular events (stroke, deep vein thrombosis, pulmonary embolism), breast cancer, and probable dementia in postmenopausal women age 65 and older. Compounded preparations are not reviewed by FDA, but the same labeled risks for the underlying hormones apply.

 

Compounded hormone preparations are not reviewed by FDA for safety or effectiveness before dispensing. They are prepared by a licensed pharmacist only in response to a valid prescription for an individual patient. Commercially available hormone therapy options should be considered first when they meet patient needs. Clinical decisions about hormone therapy should be made with a qualified prescriber.

Key Product Features

 

Estradiol and Vaginal Tissue

 

  • According to the North American Menopause Society (NAMS), estradiol is involved in maintaining vaginal mucosal tissue integrity, and low-dose topical application has been studied for genitourinary symptoms associated with menopause. Inclusion of estradiol in a compounded preparation does not establish clinical benefit for any disease, condition, or patient outcome.

 

 

Topical Delivery and Systemic Absorption

 

  • According to the FDA-approved prescribing information for estradiol, topical and vaginal routes of administration are involved in delivering the hormone locally to urogenital tissues, with limited systemic absorption compared with oral administration when used at low doses as directed. Inclusion of estradiol in a compounded topical preparation does not establish clinical benefit for any disease, condition, or patient outcome.

 

 

Estradiol and Urinary Comfort

 

  • According to NAMS, estradiol has been studied for its role in urogenital tissue, including the urethra and bladder lining, which may be affected by declining estrogen levels. Inclusion of estradiol in a compounded preparation does not establish clinical benefit for any disease, condition, or patient outcome.

 

 

Cream Base and Comfort of Application

 

  • According to pharmaceutical compounding references, cream bases used in topical hormone preparations are involved in supporting application comfort and ingredient stability; the base may be adjusted by the compounding pharmacist to meet individual patient needs as specified in the prescription. Inclusion of any base ingredient in a compounded preparation does not establish clinical benefit for any disease, condition, or patient outcome.

 

Contact Us for a Personalized Care Plan

Have questions about compounding? Contact Voshell's Pharmacy — we prepare patient-specific medications pursuant to valid prescriptions from your licensed prescriber.

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Do You Need Prescription for EstraBalance Cream

 

Do You Need a Prescription for EstraBalance Cream?

 

Whether EstraBalance Cream requires a prescription depends on its active ingredient and how it is labeled. If the preparation lists an active estrogen such as estradiol or estriol, a valid prescription from a clinician is required in the United States. Over-the-counter vaginal moisturizers and lubricants that do not contain hormones are available without a prescription.

  • Check the ingredient list: any mention of estradiol, estriol, or conjugated estrogens on the label indicates a prescription-only preparation.
  • Speak with your prescriber or pharmacist: they may confirm whether the specific preparation is prescription-only and help you understand safe dosing and relevant risk factors such as breast cancer history, clotting disorders, or liver conditions.
  • Compounded preparations: EstraBalance Cream is a compounded preparation that is not FDA-reviewed for safety or efficacy prior to dispensing; it is prepared by a licensed pharmacist only in response to a valid individual prescription. Commercially available, FDA-reviewed estrogen products should be considered first when they meet patient needs.
  • Consult your prescriber: a qualified prescriber may evaluate your medical history and, where appropriate, provide a prescription along with guidance on the lowest effective dose and necessary follow-up care.

 

Practical next steps: review the product label, speak with a pharmacist, and discuss a prescription with your clinician to determine the appropriate product and dose for your individual situation.

 

About compounded medications: Compounded medications are not FDA-approved. They have not been reviewed by the FDA for safety, effectiveness, or quality. FDA-approved medications should be considered first when commercially available options meet patient needs. Compounded preparations are prepared by licensed pharmacists in response to valid prescriptions for individual patients with specific medical needs.

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Take two capsules daily or as directed by your healthcare practitioner.

77.00/150.00

In Stock (Ships in 1-2 Business Days)

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These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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