GYNTIMA PROBIOTICA- lactic acid, folic acid, sage suppository

GYNTIMA Probiotica by

Drug Labeling and Warnings

GYNTIMA Probiotica 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

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

Purpuse

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

Inactive Ingredients

PEG 32, Lactosum, Polysorbate 20, PEG 20, Natrii Chloridum, Proteose Pepton

INSTRUCTIONS 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.

These uses are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

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.

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.

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.

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

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

Directions:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GYNTIMA PROBIOTICA 
lactic acid, folic acid, sage suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85401-020
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
HYDROLYZED CASEIN (ENZYMATIC; 1000 MW) (UNII: M93H91U80R)
PEG-32 (UNII: 1212Z7S33A)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-20 (UNII: U076Q6Q621)

Product Characteristics
Color		Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85401-020-23	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(85401-020)