SHINE PH ESSENCE- sodium hyaluronate gel

SHINE pH ESSENCE by

Drug Labeling and Warnings

SHINE pH ESSENCE by is a Otc medication manufactured, distributed, or labeled by CH BIO CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Hyaluronate

INACTIVE INGREDIENT

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

PURPOSE

feminine hygiene

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & 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.

WARNINGS

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.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHINE PH ESSENCE 
sodium hyaluronate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73305-0010
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM HYALURONATE (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	SODIUM HYALURONATE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73305-0010-1	10 in 1 PACKAGE	02/01/2025
1		1.8 g in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2025

Labeler - CH BIO CO., LTD. (694611809)

Registrant - CH BIO CO., LTD. (694611809)

Establishment
Name	Address	ID/FEI	Business Operations
CH BIO CO., LTD.		694611809	manufacture(73305-0010)