SPL v1
SPL
SPL Set ID 3c318c24-cc68-5589-e063-6394a90a8d80
Route
VAGINAL
Published
Effective Date 2025-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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. 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.


Medication Information

Warnings and Precautions

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.

Indications and Usage

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.

Dosage and Administration

Treatment: 1 suppository daily for 10 consecutive days

Prevention: 1–2 suppositories per week, long-term maintenance

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. 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.

Section 42229-5

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

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 reach of children.

If swallowed, 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 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.

Section 51727-6

PEG 32, Lactosum, Polysorbatum 20, PEG 20, Natrii chloridum, Proteose pepton, Benzalkonii chloridum

Section 51945-4

Section 55105-1

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.

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.

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.

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.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Treatment: 1 suppository daily for 10 consecutive days

Prevention: 1–2 suppositories per week, long-term maintenance

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

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

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 reach of children.

If swallowed, 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 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.

Section 51727-6 (51727-6)

PEG 32, Lactosum, Polysorbatum 20, PEG 20, Natrii chloridum, Proteose pepton, Benzalkonii chloridum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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.

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.

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.

Directions for Use: (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.


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Raw Label Data

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