ASCE PLUS DERMA SIGNAL KIT SRLV- leucine, isoleucine kit

ASCE plus Derma Signal Kit SRLV by

Drug Labeling and Warnings

ASCE plus Derma Signal Kit SRLV by is a Otc medication manufactured, distributed, or labeled by Exocobio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Leucine 0.05%, Isoleucine 0.05%

INACTIVE INGREDIENTS

[ASCE plus Derma Signal SRLV Vial 1. Lyophilized Powder]

Inactive ingredients
Rosa Damascena Callus Extracellular Vesicles, Methionine, Trehalose, Mannitol, Glutamine, Potassium Chloride, Ascorbic Acid, Retinol, Magnesium Sulfate, Glutathione, Nicotinamide Adenine Dinucleotide, Disodium Flavine Adenine Dinucleotide, Thiamine Diphosphate, Coenzyme A, sh-Oligopeptide-2, Acetyl Hexapeptide-8, Nonapeptide-1, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, sh-Oligopeptide-1, sh-Polypeptide-1, sh-Polypeptide-3, sh-Polypeptide-76, Copper Tripeptide-1, Palmitoyl Pentapeptide-4, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Lysine HCL, Ornithine HCL, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine

[ASCE plus Derma Signal SRLV Vial 2. Diluent]

Inactive ingredients
Water, Sodium Chloride, Sodium Hyaluronate, Disodium Phosphate, Sodium Phosphate, Potassium Chloride, Alanine, Arginine, Lysine HCL, Valine, Histidine, Leucine, Isoleucine, Phenylalanine, Serine, Threonine, Proline

PURPOSE

Anti Wrinkle

WARNINGS

For external use only, not to be swallowed.
In case of accidental ingestion, seek professional assistance.
Avoid contact with eyes.
If contact occurs, rinse eyes thoroughly with water.
Stop using and consult a doctor if rash or irritation develops and lasts. Keep out of reach of children. Take proper precautions when opening.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps improve wrinkle care, skin rejuvenation.

Directions

■ Mix Vial 1(Lyophilized Powder) and Vial 2(Diluent) thoroughly.
Apply a proper amount of mixture around the facial area.
* One time use ONLY.

Other Information

Store at 2℃~8℃

Questions

www.exocobio.com / sales@exocobio.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASCE PLUS DERMA SIGNAL KIT SRLV 
leucine, isoleucine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72951-100

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72951-100-01	1 in 1 CARTON; Type 0: Not a Combination Product	10/01/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL	20 mg
Part 2	1 VIAL	5.0 mL

Part 1 of 2

ASCE PLUS DERMA SIGNAL SRLV VIAL 1. LYOPHILIZED 
leucine, isoleucine powder

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Leucine (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C)	Leucine	0.01 mg  in 20 mg
Isoleucine (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)	Isoleucine	0.01 mg  in 20 mg

Inactive Ingredients
Ingredient Name	Strength
Methionine (UNII: AE28F7PNPL)
Mannitol (UNII: 3OWL53L36A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		20 mg in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2021

Part 2 of 2

ASCE PLUS DERMA SIGNAL SRLV VIAL 2. DILUENT 
leucine, isoleucine liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Leucine (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C)	Leucine	0.0025 g  in 5.0 mL
Isoleucine (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)	Isoleucine	0.0025 g  in 5.0 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5.0 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2021

Labeler - Exocobio Inc. (694828578)

Registrant - Exocobio Inc. (694828578)

Establishment
Name	Address	ID/FEI	Business Operations
Exocobio Inc.		694828578	manufacture(72951-100)