76986-021 Gembooxt Vaginal Probiotics Gel

76986-021 Gembooxt Vaginal Probiotics Gel
SPL v1
SPL
SPL Set ID 464b0e4a-6d92-9a03-e063-6294a90a6ff4
Route
VAGINAL
Published
Effective Date 2025-12-19
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) Canarium Album Whole (0.01 g) Calendula Officinalis Flower
Inactive Ingredients
Squalane Carbomer Carthamus Tinctorius Flower Bud Limosilactobacillus Fermentum Water Aloe Vera Leaf Stephania Japonica Whole Coconut Oil .alpha.-tocopherol Acetate Senna Alexandrina Seed Lithospermum Erythrorhizon Root Simmondsia Chinensis (jojoba) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-19

Description

COPTIS CHINENSIS EXTRACT 5% CANARIUM ALBUM EXTRACT 3% BORIC ACID 3 CALENDULA OFFICINALIS EXTRACT 1%


Medication Information

Warnings and Precautions

For vaginal use only.

Indications and Usage

To mitigate symptoms associated with known bacterial vaginosis infections, such as a pungent odor, excessive discharge, as well 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 applicator into 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 5% CANARIUM ALBUM EXTRACT 3% BORIC ACID 3 CALENDULA OFFICINALIS EXTRACT 1%

Section 50565-1

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

Section 50566-9



STOP USING AND ASK A DOCTOR IF:

Symptoms do not improve within 3 days.

Symptoms last more than 7 days

A rash, hives, abdominal pain, fever, chills, nausea, or vomiting occurs

lrritation becomes severe.

Section 50567-7



Ask a doctor before if you are using other vaginal medicines.

WHEN USING THIS PRODUCT:

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

Avoid vaginal intercourse.

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

Minor vaginal burning, itching, or irritation may increase.

If you are pregnant or breastfeeding, ask a health professional before use.

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

SNAKE SEED EXTRACT

ALOE VERA EXTRACT

QIAN JIN TENG EXTRACT

CARTHAMUS TINCTORIUS (SAFFLOWER) EXTRACT

LITHOSPERMUM ERYTHRORHIZON 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 5%

CANARIUM ALBUM EXTRACT 3%

BORIC ACID 3

CALENDULA OFFICINALIS EXTRACT 1%


Structured Label Content

Indications and Usage (34067-9)

To mitigate symptoms associated with known bacterial vaginosis infections, such as a pungent odor, excessive discharge, as well 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 applicator into 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 riaht away.

Section 50566-9 (50566-9)



STOP USING AND ASK A DOCTOR IF:

Symptoms do not improve within 3 days.

Symptoms last more than 7 days

A rash, hives, abdominal pain, fever, chills, nausea, or vomiting occurs

lrritation becomes severe.

Section 50567-7 (50567-7)



Ask a doctor before if you are using other vaginal medicines.

WHEN USING THIS PRODUCT:

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

Avoid vaginal intercourse.

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

Minor vaginal burning, itching, or irritation may increase.

If you are pregnant or breastfeeding, ask a health professional before use.

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

SNAKE SEED EXTRACT

ALOE VERA EXTRACT

QIAN JIN TENG EXTRACT

CARTHAMUS TINCTORIUS (SAFFLOWER) EXTRACT

LITHOSPERMUM ERYTHRORHIZON 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 5%

CANARIUM ALBUM EXTRACT 3%

BORIC ACID 3

CALENDULA OFFICINALIS EXTRACT 1%


Advanced Ingredient Data


Raw Label Data

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