SPL v1
SPL
SPL Set ID 31b83e91-bdd1-bdd1-e063-6394a90a16d7
Route
VAGINAL
Published
Effective Date 2025-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lactic Acid, Dl- (2 [hp_X]) Sage (3 [hp_X]) Folic Acid (4 [hp_X])
Inactive Ingredients
Hydrolyzed Casein (enzymatic; 1000 Mw) Peg-32 Magnesium Sulfate Sodium Chloride Lactose Monohydrate Polysorbate 20 Peg-20

Identifiers & Packaging

Pill Appearance
Shape: bullet
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-08-24

Description

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


Medication Information

Indications and Usage

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

Description

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

Section 42229-5

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

Section 44425-7

Store in a cool, dry place away from heat sources and direct sunlight.

Shelf life: 36 months from the date of manufacture.

Section 50565-1

Keep out of the reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away.

Section 51945-4

Section 55106-9

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

Section 59845-8

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.

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.

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.

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

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.

Inactive Ingredients

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


Structured Label Content

Indications and Usage (34067-9)

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

Section 42229-5 (42229-5)

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

Section 44425-7 (44425-7)

Store in a cool, dry place away from heat sources and direct sunlight.

Shelf life: 36 months from the date of manufacture.

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

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

Section 59845-8 (59845-8)

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.

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.

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.

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

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.

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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