GYNTIMA Probiotica

Manufacturer
Fytofontana LLC | Herb-Pharma AG | Herb-Pharma Corporation
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:54

Label at a glance#

ProductGYNTIMA Probiotica
Active ingredientLACTIC ACID, DL-, SAGE, FOLIC ACID
Label structure10 sections

Dosage and administration

Wash hands and intimate area thoroughly. Remove one 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. Dosage & Use: • Treatment: 1 suppository daily for 10 consecutive days • Prevention: 1–2 suppositories per week, long-term maintenance

Storage and handling

Store in a cool, dry place 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

Active Ingredients (per suppository, HPUS):

Acidum folicum 4X HPUS – Supports tissue health and repair

Acidum lacticum 2X HPUS – Supports vaginal pH balance

Extractum Salviae officinalis 3X HPUS – Traditionally used for soothing support

Magnesii sulphas 2X HPUS – Supports hydration and relief from irritation

Purpuse

OTC - PURPOSE SECTION

Purpose:

Acidum folicum – Supports tissue health and repair.

Acidum lacticum – Supports vaginal pH balance.

Extractum Salviae officinalis – Provides soothing support.

Magnesii sulphas – Supports hydration and relief from irritation.

Uses:

Helps maintain the natural balance of the vaginal microbiome.

Helps relieve discomfort, irritation, and pH imbalance.

Supports the vaginal flora balance after antibiotic treatments.

Designed to promote vaginal wellness by supporting the natural environment for beneficial bacteria to thrive.

INDICATIONS & USAGE SECTION

Women seeking preventive intimate care, particularly after:

• Antibiotic or disinfectant use

• Swimming, sexual activity, or other microbiome disturbances

• Occasional mild discomfort or irritation not requiring pharmaceutical treatment

Inactive Ingredients

INACTIVE INGREDIENT SECTION

PEG 32, Lactosum, Polysorbate 20, PEG 20, Natrii Chloridum, Proteose Pepton

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 will occur.

These uses are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

WARNINGS SECTION

Do not use during menstruation.

Do not use during pregnancy.

The vaginal suppository is intended for vaginal use only.

Do not use if the packaging appears damaged.

Do not use after the expiration date indicated on the package.

Keep out of the reach of small children.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Precautions

OTC - ASK DOCTOR SECTION

Consult your gynecologist when using vaginal preparations along with vaginal contraceptives.

If problems still persist after several days of use, consult your gynecologist.

After gynecological procedures, use only with a physician’s approval.

Any possible discoloration is due to natural plant substances in the product and is not a sign that the preparation is defective.

STORAGE AND HANDLING SECTION

Store in a cool, dry place away from heat sources and direct sunlight.
Shelf life: 36 months from the date of manufacture.

SPL UNCLASSIFIED SECTION

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

For more information, visit:
www.fytofontana.com

Directions:

DOSAGE & ADMINISTRATION SECTION

Wash hands and intimate area thoroughly.

Remove one 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.

Dosage & Use:

• Treatment: 1 suppository daily for 10 consecutive days

• Prevention: 1–2 suppositories per week, long-term maintenance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gyntima Probiotica Vaginal SuppositoryGyntima Probiotica Vaginal Suppository

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
85401-020-23GYNTIMA Probiotica2 in 1 BOXSUPPOSITORY21
85401-020-23GYNTIMA Probiotica2 in 1 BLISTER PACKSUPPOSITORY21

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85401-02085401-020-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 ProbioticaLACTIC ACID, FOLIC ACID, SAGEFytofontana LLC31b83e91-bdd1-bdd1-e063-6394a90a16d72025-04-01WarningsExact identifier
ndc (package): 85401-020-23
ndc (product): 85401-020
ndc11 (package): 85401002023
spl id: 31b83e91-bdd2-bdd1-e063-6394a90a16d7
spl set id: 31b83e91-bdd1-bdd1-e063-6394a90a16d7

Reported adverse events (FAERS/openFDA)#

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