The following Structured Product Label (SPL) was submitted to the FDA by Fytofontana Llc for the product Gyntima Probiotica (NDC 85401-020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpuse, indications & usage, inactive ingredients, instructions for use, warnings, otc - keep out of reach of children, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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.
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
PEG 32, Lactosum, Polysorbate 20, PEG 20, Natrii Chloridum, Proteose Pepton
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.
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.
Keep out of the reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away.
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.
Store in a cool, dry place away from heat sources and direct sunlight.
Shelf life: 36 months from the date of manufacture.
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
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
Gyntima Probiotica Vaginal Suppository (Hp Gyntima Probiotica Endeesit)
* Please review the disclaimer below.
