Hydro Gyn

Manufacturer
Shenzhen water element e-commerce Co., LTD
Effective date
2025-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:37

Label at a glance#

ProductHydro Gyn
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, OLEUROPEIN
Label structure8 sections

Indications and 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 moist...

Dosage and administration

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. Applic...

Storage and handling

• 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 i...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula Offcianalis 3X PHUS
Olive Extract (Oleuropein) 3X HPUS

Purpose

OTC - PURPOSE SECTION

Moisturizing and Healing Agent

Antimicrobial and Healing Agent

Uses

INDICATIONS & USAGE SECTION

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 SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a healthcare provider before using this product to ensure its safety and suitability during pregnancy or lactation.

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

STORAGE AND HANDLING SECTION

• 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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85964-001(zheng)85964-001(zheng)

85964-001(fan)85964-001(fan)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85964-001-01Hydro Gyn10 mL in 1 BAGGEL101
85964-001-01Hydro Gyn10 in 1 BOXGEL101

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85964-00185964-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3bd3a52d-eb00-1c9f-e063-6394a90abbb63bd3a52d-eaff-1c9f-e063-6394a90abbb62025-08-08WarningsExact identifier
spl id: 3bd3a52d-eb00-1c9f-e063-6394a90abbb6
spl set id: 3bd3a52d-eaff-1c9f-e063-6394a90abbb6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.