Calendula Offcianalis, Olive Extract

FDA Drug Profile — Hydro Gyn

Drug Details

Generic Name
Calendula Offcianalis, Olive Extract
Brand Names
Hydro Gyn
Application Number
Sponsor
Shenzhen water element e-commerce Co., LTD
NDC Codes
1
Dosage Forms
GEL
Routes
CUTANEOUS
Active Ingredients
CALENDULA OFFICINALIS FLOWERING TOP, OLEUROPEIN

Indications and Usage

Uses HydroGYN Vaginal Moisturizer is formulated to address symptoms associated with estrogen deficiency during menopause, perimenopause, or other vaginal changes that contribute to vaginal atrophy. It is specifically designed to provide relief from vaginal dryness, irritation, and discomfort caused by thinning and inflammation of the vaginal walls (atrophic vaginitis). By restoring and maintaining optimal vaginal moisture levels, this product helps support the natural vaginal microbiome and may assist in reducing the risk of urinary tract infections associated with vaginal atrophy. It is also suitable for managing symptoms related to menopause, perimenopause, postpartum recovery, or conditions requiring enhanced vaginal hydration.

Warnings

Warnings • For vaginal use only. • Do not use this product if you have a known allergy to any of its ingredients. • Consult your healthcare provider before use if you are pregnant, breastfeeding, or undergoing treatment for a vaginal infection. • Do not use this product if the seal is broken or missing. • In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. When using this product • Administer only as directed. Avoid exceeding the recommended application frequency. • To prevent potential desensitization or tolerance, do not use the product more than once within a 48 - hour period unless otherwise advised by a healthcare professional. • Before using this product with other therapeutic products such as douches, spermicides, or antifungal treatments, seek medical guidance to avoid interactions or diminished therapeutic efficacy. • Mild vaginal sensations, including burning, itching, or irritation, may occur initially. Should these symptoms persist, intensify, or be accompanied by abnormal discharge, bleeding, or systemic symptoms (e.g., fever, chills), discontinue use and consult a healthcare provider promptly. • Do not reuse or share the applicator to minimize the risk of contamination or infection. Dispose of the applicator after a single use. Stop Use and Consult a Healthcare Provider If • Symptoms do not improve after 3 applications or worsen during use. • You experience severe vaginal irritation, abnormal discharge, or unexpected bleeding. • Systemic symptoms such as fever, chills, or abdominal pain occur. • Premenopausal women experience any of the above - mentioned symptoms. If Pregnant or Breastfeeding Consult a healthcare provider before using this product to ensure its safety and suitability during pregnancy or lactation. keep out of reach of children This product is intended for adult use only. In case of accidental ingestion by a child, seek immediate medical attention or contact a Poison Control Center.