SPL v1
SPL
SPL Set ID 3c57cd26-bdd8-a26f-e063-6294a90a2c45
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
Soy Isoflavones Polysorbate 20 Sodium Chloride Magnesium Sulfate Hydrolyzed Casein (enzymatic; 1000 Mw) Lactose Monohydrate Peg-20 Peg-32

Identifiers & Packaging

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

Description

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.


Medication Information

Warnings and Precautions

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.

Indications and Usage

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.

Description

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.

Section 44425-7

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.

Section 50565-1

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

Section 50568-5

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.

Section 51727-6

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

Section 51945-4

Section 55105-1

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.

Section 55106-9

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.

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.

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


Structured Label Content

Indications and Usage (34067-9)

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.

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

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.

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

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.

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.

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


Advanced Ingredient Data


Raw Label Data

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