Gyntima Probiotica Forte

Manufacturer
Fytofontana LLC | Herb-Pharma AG | Herb-Pharma Corporation
Effective date
2025-08-12
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 Forte
Active ingredientSAGE, LACTIC ACID, DL-, FOLIC ACID, TEA TREE OIL
Label structure10 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 will occur.

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

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.
Extractum Salviae officinalis 3X HPUS – Helps reduce irritation and supports hydration.
Oleum Melaleucae alternifolia (Tea Tree Oil) 4X HPUS – Traditionally used in homeopathy to support the body’s natural defenses against external imbalances, helping to protect and maintain a healthy vaginal microbiome.

OTC - PURPOSE SECTION

Supports Vaginal Health

Helps maintain the natural balance of the vaginal microbiome
Supports hydration and elasticity of vaginal tissues
Helps relieve discomfort, irritation, and pH imbalance while providing natural antimicrobial support to help maintain a healthy vaginal environment and support the body's natural defense against vaginal infections.

INDICATIONS & USAGE SECTION

Lowers vaginal pH to create an unfavorable environment for harmful pathogens, while creating the ideal conditions for the body’s own beneficial bacteria, particularly Lactobacillus species, to thrive. Tea tree oil and sage extract provide additional antimicrobial effects, supporting balance and local comfort.

INACTIVE INGREDIENT SECTION

PEG 32, Lactosum, Polysorbatum 20, PEG 20, Natrii chloridum, Proteose pepton, Benzalkonii chloridum

Directions for use:

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.

WARNINGS SECTION

Warnings:

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.

Precautions:

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.

Regulatory Compliance:

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 reach of children.
If swallowed, 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 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.

DOSAGE & ADMINISTRATION SECTION

Treatment: 1 suppository daily for 10 consecutive days

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

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

Distribution:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gyntima Probiotica Forte Vaginal SuppositoriesGyntima Probiotica Forte Vaginal Suppositories

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
85401-021-24Gyntima Probiotica Forte2 in 1 BOXSUPPOSITORY21
85401-021-24Gyntima Probiotica Forte2 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
85401-02185401-021-24

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 Probiotica ForteSAGE, TEA TREE OIL, FOLIC ACID, LACTIC ACIDFytofontana LLC3c318c24-cc68-5589-e063-6394a90a8d802025-08-12WarningsExact identifier
ndc (package): 85401-021-24
ndc (product): 85401-021
ndc11 (package): 85401002124
spl id: 3c318c24-cc69-5589-e063-6394a90a8d80
spl set id: 3c318c24-cc68-5589-e063-6394a90a8d80

Reported adverse events (FAERS/openFDA)#

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