GYNTIMA MENOPAUSA- sage, lactic acid, folic acid suppository

Gyntima Menopausa by

Drug Labeling and Warnings

Gyntima Menopausa by is a Homeopathic medication manufactured, distributed, or labeled by Fytofontana LLC, Herb-Pharma AG, Herb-Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
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.

PURPOSE

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.

INACTIVE INGREDIENT

Soybean Extract, PEG 32, Lactosum, Polysorbate 20, PEG 20, Proteose Pepton, Natrii Chloridum, Sodium Hyaluronate

Directions:

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.

WARNINGS

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.

Dosage & Use

- 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

Regulatory Complaince & Manufacturing Information

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 AND HANDLING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GYNTIMA MENOPAUSA 
sage, lactic acid, folic acid suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85401-022
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4)	LACTIC ACID, DL-	2 [hp_X]
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J)	SAGE	3 [hp_X]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	4 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SOY ISOFLAVONES (UNII: 71B37NR06D)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM SULFATE (UNII: DE08037SAB)	2 [hp_X]
HYDROLYZED CASEIN (ENZYMATIC; 1000 MW) (UNII: M93H91U80R)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
PEG-20 (UNII: U076Q6Q621)
PEG-32 (UNII: 1212Z7S33A)

Product Characteristics
Color		Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85401-022-26	2 in 1 BOX	08/24/2025
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/24/2025

Labeler - Fytofontana LLC (119464729)

Registrant - Herb-Pharma AG (482440000)

Establishment
Name	Address	ID/FEI	Business Operations
Herb-Pharma Corporation		888180093	manufacture(85401-022)