HYDRO GYN- calendula offcianalis, olive extract gel

Hydro Gyn by

Drug Labeling and Warnings

Hydro Gyn by is a Homeopathic medication manufactured, distributed, or labeled by Shenzhen water element e-commerce Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HYDRO GYN 
calendula offcianalis, olive extract gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85964-001
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	3 [hp_X]  in 1 mL
OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L)	OLEUROPEIN	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
TARAXACUM MONGOLICUM (UNII: 4E8QL88U6H)
HOPS (UNII: 01G73H6H83)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AVOCADO OIL (UNII: 6VNO72PFC1)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CARBOMER (UNII: 0A5MM307FC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYALURONIC ACID (UNII: S270N0TRQY)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85964-001-01	10 in 1 BOX	08/08/2025
1		10 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/08/2025

Labeler - Shenzhen water element e-commerce Co., LTD (976726806)

Registrant - Shenzhen water element e-commerce Co., LTD (976726806)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen water element e-commerce Co., LTD		976726806	manufacture(85964-001)