PEARSYS- sodium hyaluronate kit

PEARSYS by

Drug Labeling and Warnings

PEARSYS by is a Otc medication manufactured, distributed, or labeled by J World. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium hyaluronate

INACTIVE INGREDIENT

- roller

Water
Human Fibroblast Conditioned Media
1,2-Hexanediol
Niacinamide
Sodium Hyaluronate
sh-Pentapeptide-19
sh-Octapeptide-4
Leontopodium Alpinum Callus Culture Extract
Ethylhexylglycerin
Glutathione
Galloyl Pentapeptide-33
Glycine
Glutamine
Isoleucine
Leucine
Methionine
Phenylalanine
Serine
Threonine
Tryptophan
Valine
Folic Acid
Riboflavin
Thiamine HCl
Calcium Chloride
Magnesium Sulfate
Potassium Chloride
Sodium Pyruvate
Cysteine
Arginine
Lysine
Proline
Adenosine
Glycosyl Trehalose
Hydrogenated Starch Hydrolysate
Tromethamine
Citric Acid
Hydrolyzed F-Fucoidan

- patch

Water
Acetyl hexapeptide-8 Water
Caprylyl glycol
Acetyl hexapeptide-8
Sodium hyaluronate
Cellulose gum
Lactose
Glycerin
Marigold Extract HD Water
Calendula officinalis flower extract
1,2-Hexanediol
Licorice Extract HD Water
Glycyrrhiza uralensis (licorice) root extract
1,2-Hexanediol
GH-815 Propanediol
Caprylyl glycol
Ethylhexyl glycerin
Madecassoside

PURPOSE

DMS (Dissolving Micro Structure) Technology Microchip gives minute skin stimulation to help skin concentrate and absorb active ingredients

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

spread water soluble cosmetics all over your face before using

open one sterilized micro chip roller for use

press the left pushbutton of the dedicated roller handle to insert a micro chip roller

gently rolls massages along the fact surface from inside to outside

use only until you feel no stimulation from the micro chip

after using, apply cosmetics evenly across face

after using, press the roller handle depressor to discard the micro chip roller (the micro chip roller is disposable)

dedicated roller handle keeps it clean with a continous use product

(this product is recommended to use one every 2 to 3 days)

WARNINGS

Use it for your own use only.

For external use only.

Discontinue use if adverse reaction occurs.

Contact a physician if symptoms persist.

Store at room temperature

.Do not reuse it as a disposable product.

Please use it immediately after opening.

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEARSYS 
sodium hyaluronate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72945-0004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72945-0004-1	1 in 1 BOX; Type 0: Not a Combination Product	07/21/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 PATCH	180 mL
Part 2	1 BOTTLE, GLASS	3.3 mL

Part 1 of 2

PEARSYS 
sodium hyaluronate patch

Product Information
Item Code (Source)	NDC: 72945-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	6.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72945-0005-1	45 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/26/2019

Part 2 of 2

AMPLE 
sodium hyaluronate liquid

Product Information
Item Code (Source)	NDC: 72945-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	0.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ADENOSINE (UNII: K72T3FS567)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72945-0006-1	3.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/21/2019

Labeler - J World (690082781)

Registrant - J World (690082781)

Establishment
Name	Address	ID/FEI	Business Operations
J World		690082781	manufacture(72945-0004) , label(72945-0004)