FDA Label for Hydro Gyn
View Indications, Usage & Precautions
Hydro Gyn Product Label
The following document was submitted to the FDA by the labeler of this product Shenzhen Water Element E-commerce Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Calendula Offcianalis 3X PHUS
Olive Extract (Oleuropein) 3X HPUS
Purpose
Moisturizing and Healing Agent
Antimicrobial and Healing Agent
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
• 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.
Other Information
• Do not use this product if the sealed packaging is compromised, damaged, or previously opened.
• Store at a controlled temperature of 20°C to 25°C (68°F to 77°F).
• Protect the product from direct sunlight as excessive ultraviolet (UV) rays may degrade the product stability.
• Temporary deviations outside this range are acceptable but should be minimized to preserve product and effectiveness of the homeopathic ingredients.
• If the product is frozen, thaw it before use.
• Always store the product in a dark, cool, and dry location.
Directions
Preparation:
Place a sanitary panty liner in your underwear to prevent any potential leakage.
Carefully open the sealed foil pouch and remove the pre - filled applicator. Do not tamper with the applicator tip until ready for use.
Positioning:
Recline in a comfortable position on your back with your knees bent to facilitate insertion.
Alternatively, you may stand or sit, based on your preference and comfort.
Application:
Gently insert the thin end of the applicator into the vaginal opening until comfortable.
Firmly press the thick end of the applicator to dispense the product completely into the vaginal canal.
Post - Application:
Remove and discard the applicator immediately after use. Do not attempt to reuse.
Be aware that a slight increase in vaginal burning, itching, or irritation may occur temporarily as your body adjusts to the product.
If these symptoms persist or worsen, consult a healthcare provider.
Ensure to follow these instructions carefully for optimal results and safety.
Inactive Ingredients
Purified water, Hyaluronic Acid 0.05%, Tocopherol Acetate (Vitamin E), Carbomer, Carbomer, Sodium Hyaluron Hydroxide, Sodium Edetate, Hop extract, Organic Olive Oil, Organic Avocado Oil, Olive Fruit Vilin Extract, Taraxacum Mongolicum Extract
85964-001-01
* Please review the disclaimer below.
