PRESTIGE CAVIAR SUPER AQUA SERUM- niacinamide, adenosine cream 
FW1 R&D_Branch

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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Drug Facts

Niacinamide 2.00%
Adenosine 0.04%

Skin Protectant

To provide hydration and promote attractiveness to skin

Apply gently over clean, dry skin or/and desired area 1 to 2 times daily

For morning and evening use

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

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Caviar Extract, Butylene Glycol, Water, Glycerin, Glycereth-26, Linum Usitatissimum (Linseed) Seed Extract, 1,2-Hexanediol, Pentylene Glycol, Polyglycerin-3, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate, Phenoxyethanol, PEG-60 Hydrogenated Castor Oil, Carbomer, Tromethamine
, Panthenol, Diphenyl Dimethicone, Triethylhexanoin, Fragrance(Parfum), Acacia Senegal Gum, Polyglutamic Acid, Hydrogenated Lecithin, Disodium EDTA, Peat Water, Citric Acid, Hydroxypropyl Methylcellulose, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polydecene, Saccharide Isomerate, Potassium Sorbate, Hydrolyzed Myrtus Communis Leaf Extract, Caprylic/Capric Triglyceride, Zingiber Officinale (Ginger) Root Extract, Sorbitan Laurate, Squalane, Viscum Album (Mistletoe) Fruit Extract, Pancratium Maritimum Extract, Ethylhexylglycerin, Ceramide 3, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Sodium Citrate, Prunus Persica (Peach) Flower Extract

image description

PRESTIGE CAVIAR SUPER AQUA SERUM 
niacinamide, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70519-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1 mg  in 50 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.02 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERETH-26 (UNII: NNE56F2N14)  
FLAX SEED (UNII: 4110YT348C)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
TROMETHAMINE (UNII: 023C2WHX2V)  
PANTHENOL (UNII: WV9CM0O67Z)  
DIPHENYL DIMETHICONE (400 CST) (UNII: Y5MXX82OQ7)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ACACIA (UNII: 5C5403N26O)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
HYDROGENATED DIDECENE (UNII: 048B98MT5O)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MYRTUS COMMUNIS LEAF (UNII: U20N87188F)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GINGER (UNII: C5529G5JPQ)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
SQUALANE (UNII: GW89575KF9)  
VISCUM ALBUM FRUIT (UNII: P83EQ521R3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CERAMIDE NP (UNII: 4370DF050B)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70519-005-021 in 1 PACKAGE06/27/2017
1NDC:70519-005-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/27/2017
Labeler - FW1 R&D_Branch (689605458)
Registrant - FW1 R&D_Branch (689605458)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(70519-005)

Revised: 6/2017
Document Id: f8214ce0-2c44-4fa2-8a17-2054d944f95c
Set id: 2a86b7b6-761d-4ec8-aa2c-5c32bb6c3a35
Version: 3
Effective Time: 20170627
 
FW1 R&D_Branch