Gyntima Menopausa

Manufacturer
Fytofontana LLC | Herb-Pharma AG | Herb-Pharma Corporation
Effective date
2025-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:54

Label at a glance#

ProductGyntima Menopausa
Active ingredientLACTIC ACID, DL-, SAGE, FOLIC ACID
Label structure9 sections

Dosage and administration

Wash hands and intimate area thoroughly. Remove the suppository from the blister pack. Insert deeply into the vagina, preferably in the evening before bed. Use a sanitary pad, as minor discharge may occur.

Storage and handling

Storage: Store in a cool, dry place at 5–25°C (41–77°F), away from heat sources and direct sunlight. Shelf life: 36 months from the date of manufacture.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acidum folicum 4X HPUS – Contributes to the regeneration and repair of vaginal tissues.
Acidum lacticum 2X HPUS – Helps regulate vaginal pH and supports microbiome balance.
Magnesii sulphas 2X HPUS – Helps soothe irritation and maintain moisture balance in vaginal tissues.
Extractum Salviae officinalis 3X HPUS – Traditionally used for its soothing properties and to support vaginal mucosal health.

OTC - PURPOSE SECTION

Acidum folicum – Supports vaginal tissue regeneration and repair.
Acidum lacticum – Regulates vaginal pH and microbiome balance.
Magnesii sulphas – Soothes irritation and maintains vaginal moisture balance.
Extractum Salviae officinalis – Supports vaginal mucosal health and soothes irritation.
Soybean Extract – Supports hydration and comfort during menopause.

INDICATIONS & USAGE SECTION

Helps restore and maintain natural vaginal moisture levels, supporting comfort during menopause.
Supports natural hydration and helps maintain the elasticity of vaginal tissues.
Assists in relieving vaginal dryness, discomfort, itching, and sensitivity caused by hormonal changes.
Designed to support the natural balance of the vaginal microbiome and mucosa.

INACTIVE INGREDIENT SECTION

Soybean Extract, PEG 32, Lactosum, Polysorbate 20, PEG 20, Proteose Pepton, Natrii Chloridum, Sodium Hyaluronate

Directions:

INSTRUCTIONS FOR USE SECTION

Wash hands and intimate area thoroughly.
Remove the suppository from the blister pack.
Insert deeply into the vagina, preferably in the evening before bed.
Use a sanitary pad, as minor discharge may occur.

WARNINGS SECTION

For vaginal use only.
Do not use if the packaging appears damaged.
Do not use after the expiration date indicated on the packaging.
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

OTC - ASK DOCTOR/PHARMACIST SECTION

Consult your gynecologist when using vaginal preparations along with vaginal contraceptives.
If symptoms persist after several days of use, consult your gynecologist.
After gynecological procedures, use only with a physician’s approval.
Any slight color variation or sediment is due to natural plant ingredients and does not affect product quality.

Dosage & Use

DOSAGE & ADMINISTRATION SECTION

- Treatment: 1 suppository daily, preferably in the evening at bedtime, after completing the

evening hygiene routine

- Prevention: as advised by a gynecologist, depending on individual needs

Regulatory Complaince & Manufacturing Information

SPL UNCLASSIFIED SECTION

The active ingredients in this product are prepared in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS). These uses are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Distributed by:
Fytofontana LLC
382 NE 191st St PMB 850628
Miami, Florida 33179-3899 USA

Manufacturer:
Herb-Pharma Corporation s.r.o., 935 65 Veľké Ludince, Slovakia
Under license from Herb-Pharma AG Schweiz, Waldmannstrasse 6, 8001 Zürich, Switzerland

STORAGE AND HANDLING SECTION

Storage:

Store in a cool, dry place at 5–25°C (41–77°F), away from heat sources and direct sunlight.
Shelf life: 36 months from the date of manufacture.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gyntima MenopausaGyntima Menopausa

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85401-022-26Gyntima Menopausa2 in 1 BOXSUPPOSITORY21
85401-022-26Gyntima Menopausa2 in 1 BLISTER PACKSUPPOSITORY21

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85401-02285401-022-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
Gyntima MenopausaSAGE, LACTIC ACID, FOLIC ACIDFytofontana LLC3c57cd26-bdd8-a26f-e063-6294a90a2c452025-08-14WarningsExact identifier
ndc (package): 85401-022-26
ndc (product): 85401-022
ndc11 (package): 85401002226
spl id: 3c57cd26-bdd9-a26f-e063-6294a90a2c45
spl set id: 3c57cd26-bdd8-a26f-e063-6294a90a2c45

Reported adverse events (FAERS/openFDA)#

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