FDA Label for Gyntima Probiotica Forte
View Indications, Usage & Precautions
Gyntima Probiotica Forte Product Label
The following document was submitted to the FDA by the labeler of this product Fytofontana Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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
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
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
PEG 32, Lactosum, Polysorbatum 20, PEG 20, Natrii chloridum, Proteose pepton, Benzalkonii chloridum
Directions For Use:
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
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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Ask Doctor/Pharmacist
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
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.
Other
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
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