The following Structured Product Label (SPL) was submitted to the FDA by Fytofontana Llc for the product Gyntima Menopausa (NDC 85401-022). 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, otc - purpose, indications & usage, inactive ingredient, directions:, warnings, otc - keep out of reach of children, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
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.
Soybean Extract, PEG 32, Lactosum, Polysorbate 20, PEG 20, Proteose Pepton, Natrii Chloridum, Sodium Hyaluronate
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.
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.
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
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.
- 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
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:
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.
Gyntima Menopausa (Hp Gyntima Menopausa Endeesit)
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