Label: PRESTIGE CAVIAR NOURISHING DAILY CREAM- glycerin, dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 27, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Glycerin 27.36%
    Dimethicone 2.00%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Helps to prevent dehydration of skin

  • DOSAGE & ADMINISTRATION

    Apply liberally as needed onto skin

  • WARNINGS

    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

    Keep out of reach of children.

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

  • INACTIVE INGREDIENT

    Caviar Extract, Cyclopentasiloxane, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Butylene Glycol, Glycereth-26, Niacinamide, 1,2-Hexanediol, PEG/PPG-19/19 Dimethicone, Methyl Gluceth-20, Sodium Glutamate, Phenoxyethanol, PEG-7 Dimethicone, PEG/PPG-20/20 Dimethicone, Fragrance(Parfum), Dipotassium Glycyrrhizate, Adenosine, Iron Oxides (CI 77499), Synthetic Fluorphlogopite, Sodium Citrate, C12-14 Pareth-12, Titanium Dioxide (CI 77891), Disodium EDTA, Aqua, Polydecene, Saccharide Isomerate, Hydrolyzed Rice Protein, Caprylic/Capric Triglyceride, Sorbitan Laurate, Squalane, Hydrogenated Lecithin, Viscum Album (Mistletoe) Fruit Extract, Sodium Benzoate, Superoxide Dismutase, Glycine Soja (Soybean) Protein, Ceramide 3, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Citric Acid, Sodium Dextran Sulfate, Potassium Sorbate, Prunus Persica (Peach) Flower Extract

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PRESTIGE CAVIAR NOURISHING DAILY CREAM 
    glycerin, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70519-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN13.7 mg  in 50 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ADENOSINE (UNII: K72T3FS567)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    C12-14 PARETH-12 (UNII: M0LJS773XW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGENATED DIDECENE (UNII: 048B98MT5O)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    SQUALANE (UNII: GW89575KF9)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    VISCUM ALBUM FRUIT (UNII: P83EQ521R3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LEDISMASE (UNII: 0786H5RV0T)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70519-004-021 in 1 PACKAGE06/27/2017
    1NDC:70519-004-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/27/2017
    Labeler - FW1 R&D_Branch (689605458)
    Registrant - FW1 R&D_Branch (689605458)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(70519-004)