CLUEDERM AQUA SOLUTION REJUVE PLUS- hyaluronate sodium liquid 
CLASSYS INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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70017-002_Cluederm Aqua Solution Rejuve Plus

HYALURONATE SODIUM 4.00%

Skin Protectant

for even skin tone and firming

- Apply the solution only for depositing Hyaluronic Acid, Peptides, and antioxidants into the skin following exfoliation


For external use only
Do not use on damaged or broken skin
Stop using and ask a doctor if rash occurs
When using this product, keep out of eyes. Rinse with water to remove

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Glycerin, Sericin, Hydroxyethylcellulose, Aesculus Hippocastanum (Horse Chestnut) Extract, Royal Jelly Extract, Morus Alba Bark Extract, Hydrolyzed Yeast Extract, Panax Ginseng Root Extract, Butylene Glycol, Phenoxyethanol, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Curcuma Longa (Turmeric) Root Extract, Avena Sativa (Oat) Kernel Extract, Sodium Benzoate, Papain, Sodium Hydroxide, Citric Acid, Centella Asiatica Extract, Ecklonia Cava Extract, Hizikia Fusiforme Extract, Codium Tomentosum Extract, Gelidium Cartilagineum Extract, Ocimum Sanctum Leaf Extract, Ethyl Hexanediol, Leucojum Aestivum Bulb Extract, Hyacinthus Orientalis Extract, Hydrolyzed Collagen, Acetyl Hexapeptide-8, 1,2-Hexanediol, Corallina Officinalis Extract, Melia Azadirachta Extract

image description

CLUEDERM AQUA SOLUTION REJUVE PLUS 
hyaluronate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70017-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM20 mg  in 500 mL
Inactive Ingredients
Ingredient NameStrength
CORALLINA OFFICINALIS (UNII: 4004498D06)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SERICIN 1 (UNII: N6466G03F7)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
ROYAL JELLY (UNII: L497I37F0C)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
TURMERIC (UNII: 856YO1Z64F)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PAPAIN (UNII: A236A06Y32)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECKLONIA CAVA (UNII: UXX2N5V39P)  
CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
OCIMUM TENUIFLORUM LEAF OIL (UNII: KRP8S57T49)  
ETHOHEXADIOL (UNII: M9JGK7U88V)  
LEUCOJUM AESTIVUM BULB (UNII: 190M641M70)  
HYACINTHUS ORIENTALIS WHOLE (UNII: 33J37WGZ7H)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70017-002-01150 mL in 1 CONTAINER; Type 0: Not a Combination Product06/28/201803/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/28/201803/29/2019
Labeler - CLASSYS INC. (689842183)
Registrant - CLASSYS INC. (689842183)
Establishment
NameAddressID/FEIBusiness Operations
Genicos Co., Ltd.688454362manufacture(70017-002)

Revised: 3/2019
Document Id: 854080fd-65c2-0829-e053-2a91aa0abaa5
Set id: 3a3e90ef-7655-437a-b023-1d8de197a35c
Version: 3
Effective Time: 20190329
 
CLASSYS INC.