GYNTIMA PROBIOTICA FORTE- sage, tea tree oil, folic acid, lactic acid suppository

Gyntima Probiotica Forte by

Drug Labeling and Warnings

Gyntima Probiotica Forte 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.
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.

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.

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.

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GYNTIMA PROBIOTICA FORTE 
sage, tea tree oil, folic acid, lactic acid suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85401-021
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J)	SAGE	3 [hp_X]
LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4)	LACTIC ACID, DL-	2 [hp_X]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	4 [hp_X]
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	4 [hp_X]

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

Product Characteristics
Color		Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85401-021-24	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(85401-021)