ASCE PLUS DERMA SIGNAL KIT SRLV S- leucine, isoleucine kit

ASCE plus Derma Signal Kit SRLV S by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Leucine 0.004%, Isoleucine 0.003%

INACTIVE INGREDIENT

[Vial 1. Lyophilized Powder]

Inactive ingredients
Water, Methionine, Trehalose, Mannitol, Glutamine, Potassium Chloride, Ascorbic Acid, Retinol, Magnesium Sulfate, Alanine, Arginine, Lysine HCL, Tryptophan, Tyrosine, Valine, Glutathione, Histidine, Leucine, Isoleucine, Phenylalanine, Aspartic Acid, Glycine, Glutamic acid, Serine, Ornithine HCL, Threonine, Proline, Nicotinamide Adenine Dinucleotide, Coenzyme A, Acetyl Hexapeptide-8, Nonapeptide-1, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Thiamine Diphosphate, Disodium Flavine Adenine Dinucleotide, Copper Tripeptide-1, Palmitoyl Pentapeptide-4

[Vial 2. Ampoule]

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

PURPOSE: Anti Wrinkle

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses
■ Helps improve wrinkle care, skin rejuvenation.

Directions

Directions:

Mix Vial 1(Lyophilized POWDER) and Vial 2(Ampoule) thoroughly.
To absorb the product well, apply a proper amount of mixture around the facial area.
* Must be single use, do not reuse.

Single Package Image

Outer Package Image

INGREDIENTS AND APPEARANCE

ASCE PLUS DERMA SIGNAL KIT SRLV S 
leucine, isoleucine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72951-010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72951-010-01	1 in 1 CARTON; Type 0: Not a Combination Product	03/01/2019

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

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	0.0008 mg  in 20 mg
Isoleucine (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)	Isoleucine	0.0006 mg  in 20 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Methionine (UNII: AE28F7PNPL)

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		03/01/2019

Part 2 of 2

VIAL 2 AMPOULE 
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	0.0002 g  in 5.0 mL
Isoleucine (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)	Isoleucine	0.0001 g  in 5.0 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)

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		03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2019

Labeler - Exocobio Inc. (694828578)

Registrant - Exocobio Inc. (694828578)

Establishment
Name	Address	ID/FEI	Business Operations
Exocobio Inc.		694828578	manufacture(72951-010)