SPL v1
SPL
SPL Set ID 2edc4479-fb5a-d8a9-e063-6394a90a0db3
Route
VAGINAL
Published
Effective Date 2017-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hyaluronic Acid (0.5 g)
Inactive Ingredients
Water Glycerin Centella Asiatica Leaf

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-02-01

Description

Sodium Hyaluronate


Medication Information

Warnings and Precautions

Precautions for Use

If you experience abnormal symptoms or side effects such as red spots, swelling, or itching on the area of use during or after using the cosmetic product due to direct sunlight, consult with a specialist.

Avoid using on areas with wounds.

Precautions for storage and handling:

Keep out of reach of children.

Store away from direct sunlight.

Use only on the vulva, do not use inside the vagina.

Follow the prescribed usage and dosage carefully.

Do not use on infants and toddlers under 3 years old.

It is advisable not to use during pregnancy, and do not use on the area around the vulva immediately before delivery.

Indications and Usage

Step 1

Wash your hands thoroughly before opening the product packaging.

Step 2

Hold the handle and partially remove the product. Then pull on the cap portion of the packaging to remove it along with the packaging.

Step 3

Holding the handle, press the plunger all the way down to apply the entire contents to the vulva.

Step 4

After use, gently rinse with water. Dispose of the used product along with its packaging.

Dosage and Administration

for external use only



Description

Sodium Hyaluronate

Section 50565-1

keep out or reach of the children

Section 51727-6

Centella Asiatica Leaf Water

Glycerin

1,2-Hexanediol

Dipropylene Glycol

Hydroxyethylcellulose

Water

Melaleuca Alternifolia (Tea Tree) Leaf Extract

Punica Granatum Fruit Extract

Royal Jelly Extract

Anemarrhena Asphodeloides Root Extract

Hydroxyacetophenone

Caprylyl Glycol

Butylene Glycol

Citric Acid

PEG-60 Hydrogenated Castor Oil

Propanediol

Adenosine

Disodium EDTA

Benzyl Glycol

Hydrolyzed Glycosaminoglycans

Dipotassium Glycyrrhizate

Sodium Hyaluronate Crosspolymer

Hydrolyzed Hyaluronic Acid

Ethylhexylglycerin

Hydroxypropyltrimonium Hyaluronate

Hyaluronic Acid

Sodium Acetylated Hyaluronate

Section 51945-4

Section 55105-1

feminine hygiene

Section 55106-9

Sodium Hyaluronate


Structured Label Content

Indications and Usage (34067-9)

Step 1

Wash your hands thoroughly before opening the product packaging.

Step 2

Hold the handle and partially remove the product. Then pull on the cap portion of the packaging to remove it along with the packaging.

Step 3

Holding the handle, press the plunger all the way down to apply the entire contents to the vulva.

Step 4

After use, gently rinse with water. Dispose of the used product along with its packaging.

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

Precautions for Use

If you experience abnormal symptoms or side effects such as red spots, swelling, or itching on the area of use during or after using the cosmetic product due to direct sunlight, consult with a specialist.

Avoid using on areas with wounds.

Precautions for storage and handling:

Keep out of reach of children.

Store away from direct sunlight.

Use only on the vulva, do not use inside the vagina.

Follow the prescribed usage and dosage carefully.

Do not use on infants and toddlers under 3 years old.

It is advisable not to use during pregnancy, and do not use on the area around the vulva immediately before delivery.

Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

Centella Asiatica Leaf Water

Glycerin

1,2-Hexanediol

Dipropylene Glycol

Hydroxyethylcellulose

Water

Melaleuca Alternifolia (Tea Tree) Leaf Extract

Punica Granatum Fruit Extract

Royal Jelly Extract

Anemarrhena Asphodeloides Root Extract

Hydroxyacetophenone

Caprylyl Glycol

Butylene Glycol

Citric Acid

PEG-60 Hydrogenated Castor Oil

Propanediol

Adenosine

Disodium EDTA

Benzyl Glycol

Hydrolyzed Glycosaminoglycans

Dipotassium Glycyrrhizate

Sodium Hyaluronate Crosspolymer

Hydrolyzed Hyaluronic Acid

Ethylhexylglycerin

Hydroxypropyltrimonium Hyaluronate

Hyaluronic Acid

Sodium Acetylated Hyaluronate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

feminine hygiene

Section 55106-9 (55106-9)

Sodium Hyaluronate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)