Label: ROYAL GINSENG ESSENCE- niacinamide liquid

  • NDC Code(s): 75694-0003-1
  • Packager: Green Life Agricultural Corporation
  • 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 December 5, 2020

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

  • ACTIVE INGREDIENT

    niacinamide

  • INACTIVE INGREDIENT

    Water
    Propylene Glycol
    Glycerin
    PEG-7 Glyceryl Cocoate
    Panax Ginseng Leaf/Root/Stem Extract
    Sodium Hyaluronate
    1,2-hexanediol, Caprylyl Glycol
    Acrylates/C10-30 Alkyl Acrylate Crosspolymer
    Arginine
    Allantoin
    Polyglyceryl-10 Laurate, Polyglyceryl-4 Laurate, Caprylyl/Capryl Glucoside
    Tocopheryl Acetate
    Fragrance

  • PURPOSE

    Moisturizing effects
    Whitening effects Anti-inflammatory
    effects, antacid effects Anti-aging effects
    on skin (anti-oxidation effects)

  • WARNINGS

    ■ if following abnormal symptoms persist, discontinue use

    Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

    ■ Stop immediately and consult a doctor if you experience

    1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

    2) Skin Irritation

    3) Following Instructions when using medication

    (1) For external use only (Do not use internally)

    (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

    ■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

    ■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

    It is not recommended to use this one areas that have been medically treated with a cast or bandage.

    ■ Do not use in combination with soap or antibacterial cleansing agents.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep Out of Reach of Children.

  • INDICATIONS & USAGE

    apply proper amount to the skin

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ROYAL GINSENG ESSENCE 
    niacinamide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75694-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75694-0003-150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/04/2020
    Labeler - Green Life Agricultural Corporation (694822215)
    Registrant - Green Life Agricultural Corporation (694822215)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bioncell Co., Ltd688438655manufacture(75694-0003)