Label: PRIMEROSE SNAIL HYDRO ESSENCE- niacinamide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated January 15, 2019

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

  • Active ingredient

    Niacinamide (2%)

  • Purpose

    skin protectant

  • Keep out of reach of children

    - Do not swallow. In case of accidental ingestion, seek professional assistance.

  • Uses

    Skin brightening and keep skin soft and smooth.

  • Warnings

    For external use only
    Do not use when Your skin is red, inflamed, irritated or painful
    When using this product
    - Do not apply on other parts of the body
    - Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    - Do not apply directly to wound or open cut.
    Stop use and ask doctor if rash or irritation on skin develops and lasts.
    Store at room temperature

  • Directions

    Apply adequate amount in the palm of hand, softly rub onto face and body until bubbles form. Massage gently.

  • Inactive ingredients

    Snail Secretion Filtrate, Cyclohexasiloxane, Cyclopentasiloxane, Water, Glycerin, Sodium hyaluronate, Butylene Glycol, Phenyl trimethicone, Lactobacillus/Portulaca oleracea Ferment Filtrate, Soybean Extract Ferment Filtrate, Punica Granatum Fruit Ferment Extract, Phellius Baumiimycelium, Panax Ginseng Root Ferment Extract Filtrate, Dimethicone crosspolymer, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Macadamia integrifolia seed oil, Hydroxyethylcellulose, Methylparaben, Phenoxyethanol, Sodium EDTA, Fragrance

  • PRIMEROSE SNAIL HYDRO GEL ESSENCE

    hydro gel

  • INGREDIENTS AND APPEARANCE
    PRIMEROSE SNAIL HYDRO ESSENCE 
    niacinamide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69888-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    SNAIL, UNSPECIFIED (UNII: 2VIO5GL90I)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69888-104-021 in 1 PACKAGE02/13/2018
    1NDC:69888-104-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/13/2018
    Labeler - Royal Springs Cosmetics USA, LLC (079837692)
    Registrant - Royal Springs Cosmetics USA, LLC (079837692)
    Establishment
    NameAddressID/FEIBusiness Operations
    Royal Springs Cosmetics USA, LLC079837692relabel(69888-104)
    Establishment
    NameAddressID/FEIBusiness Operations
    Royal Springs Cosmetic Co.,Ltd.689514344manufacture(69888-104)