76986-017 Precilyx Vaginal Probiotics Gel

76986-017 Precilyx Vaginal Probiotics Gel
SPL v3
SPL
SPL Set ID 45a961eb-a156-0597-e063-6294a90ad45f
Route
VAGINAL
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Boric Acid (0.03 g) Coptis Chinensis Root (0.05 g) Calendula Officinalis Flower (0.01 g) Canarium Album Whole
Inactive Ingredients
Aloe Vera Leaf Limosilactobacillus Fermentum Carthamus Tinctorius Flower Bud Cnidium Seed Carbomer Cocos Nucifera (coconut) Oil Stephania Japonica Whole .alpha.-tocopherol Acetate Simmondsia Chinensis (jojoba) Seed Oil Pseudotsuga Menziesii Whole Water Squalane Lithospermum Erythrorhizon Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-11

Description

COPTIS CHINENSIS EXTRACT CANARIUM ALBUM EXTRACT BORIC ACID CALENDULA OFFICINALIS EXTRACT


Medication Information

Warnings and Precautions

For vaginal use only.

Indications and Usage

To mitigate symptoms associated with knownbacterial vaginosis infections, such as apungent odor, excessive discharge, as wel!as discomfort and burning during urination.

Dosage and Administration



Adults and children 12 years and older:

1.Thoroughly wash your hands and the external vaginal area.

2.Remove the bottom cover and the top cap.

3.Attach the top cap to the base.

4.Press plunger gently.

5.Lie on your back with your knees bent Gently insert the applicatorinto the vagina and press plunger fully to release the gel.

6.Withdraw and discard the applicator.

7.Use one applicatorful daily, preferably at bedtime

Children under 12 years: Consult a health professional.

Description

COPTIS CHINENSIS EXTRACT CANARIUM ALBUM EXTRACT BORIC ACID CALENDULA OFFICINALIS EXTRACT

Section 50565-1

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

Section 50566-9



Symptoms do not improve within 3 days.

Symptoms last more than 7 days.

A rash, hives, abdominal pain, fever, chills, nausea, or vomiting occurslrritation becomes severe.

Section 50567-7



Do not use tampons, douches, spermicides, or other vaginal products.

Avoid vaginal intercourse.

This product may damage condoms and diaphragms, making them less effective at preventing pregnancy or sexually transmitted infections (STls)

Minor vaginal buring, itching, or irritation may increase.

Section 50570-1

Do not use if you have not been diagnosed by a doctor with bacterial vaginosis.

Section 51727-6

Water, Lactobacillus Ferment Lysate, Huanghuai Extract, Huangshan Extract, Snake SeedExtract, Vaginal Probiotics, Aloe Vera Extract, Qian Jin Teng Extract, Carthamus Tinctorius(Safflower) Extract, Lithospermum Ervthrorhizon Extract, Cocos Nucifera (Coconut) Oil.Tocopheryl Acetate,Squalane, Simmondsia Chinensis (Jojoba) Seed Oil. Carbomer

Section 51945-4

Section 55105-1

Antimicrobial

Section 55106-9

COPTIS CHINENSIS EXTRACT

CANARIUM ALBUM EXTRACT

BORIC ACID

CALENDULA OFFICINALIS EXTRACT


Structured Label Content

Indications and Usage (34067-9)

To mitigate symptoms associated with knownbacterial vaginosis infections, such as apungent odor, excessive discharge, as wel!as discomfort and burning during urination.

Dosage and Administration (34068-7)



Adults and children 12 years and older:

1.Thoroughly wash your hands and the external vaginal area.

2.Remove the bottom cover and the top cap.

3.Attach the top cap to the base.

4.Press plunger gently.

5.Lie on your back with your knees bent Gently insert the applicatorinto the vagina and press plunger fully to release the gel.

6.Withdraw and discard the applicator.

7.Use one applicatorful daily, preferably at bedtime

Children under 12 years: Consult a health professional.

Warnings and Precautions (34071-1)

For vaginal use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)



Symptoms do not improve within 3 days.

Symptoms last more than 7 days.

A rash, hives, abdominal pain, fever, chills, nausea, or vomiting occurslrritation becomes severe.

Section 50567-7 (50567-7)



Do not use tampons, douches, spermicides, or other vaginal products.

Avoid vaginal intercourse.

This product may damage condoms and diaphragms, making them less effective at preventing pregnancy or sexually transmitted infections (STls)

Minor vaginal buring, itching, or irritation may increase.

Section 50570-1 (50570-1)

Do not use if you have not been diagnosed by a doctor with bacterial vaginosis.

Section 51727-6 (51727-6)

Water, Lactobacillus Ferment Lysate, Huanghuai Extract, Huangshan Extract, Snake SeedExtract, Vaginal Probiotics, Aloe Vera Extract, Qian Jin Teng Extract, Carthamus Tinctorius(Safflower) Extract, Lithospermum Ervthrorhizon Extract, Cocos Nucifera (Coconut) Oil.Tocopheryl Acetate,Squalane, Simmondsia Chinensis (Jojoba) Seed Oil. Carbomer

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

COPTIS CHINENSIS EXTRACT

CANARIUM ALBUM EXTRACT

BORIC ACID

CALENDULA OFFICINALIS EXTRACT


Advanced Ingredient Data


Raw Label Data

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