Label: PLU BODY SCRUB PRESTIGE SILK EDITION- glycerin body scrub lotion

  • 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 16, 2019

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  • ACTIVE INGREDIENT

    Glycerin (3.8%) - Skin Protectant

  • INACTIVE INGREDIENT

    Disodium Laureth Sulfosuccinate, Juglans Regia (Walnut) Shell Powder, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Punica Granatum Fruit Extract, Honey Extract, Rosa Hybrid Flower Extract, Prunus Serrulata Flower Extract, Chrysanthemum Morifolium Flower Extract, Fragrance, Triethanolamine, Laureth-9, Vitis Vinifera (Grape) Seed Powder, Hydrolyzed Silk, Fibrion, Sericin, Camellia Sinensis Leaf Extract, Rosa Davurica Bud Extract, Ligularia Fishceria Leaf Extract, Sapindus Mukurossi Peel Extract, Adansonia Digitata Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Rosa Canica Fruit Oil, Spirulina Platensis Extract, Anastatica Hierochuntica Extract, Cabrormer, Sodium Hyaluronate, Disodium Lauroyl Glutamate, Ascorbic Acid, Polyquaternium-10, Collagen Extract, Phenoxyethanol, Disodium EDTA, Ethylhexylglycerin

  • PURPOSE

    Skin Protectant

  • WARNINGS

    The safety of this product has not been determined.
    1. Stop using of this product if any below symptom is found. Continuous use may worsen the symptom. Please contact dermatologist. a. In case of any troubles, such as red spots, swollen skin, itchy or irritation. b. In case of any trouble on applied area as above due to direct light.
    2. Do not apply on trouble area such as wound, eczema or dermatitis.
    3. Cautions for storage and handling a. After use, make sure to close cap. b. Keep away from reach of children. c. Do not keep in area where temperature is too hight or too low and avoid direct light.
    4. Do not use other than product's specified application.
    5. In case of use for baby or children, be careful not to rub eyes or put into mouth.
    6. Excessive rubbing may cause wound.
    7. Adjust application frequency by type of skin.
    8. This is a scrub product especially for body. Do not apply to face
    9. In use, be careful not have scrub particles get into eyes.
    10. When particle gets into eyes, do not rub but wash out with water. If particle resides in eyes, please consult with medical doctor.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Wet Skin. Apply scrub on face and gently massage except eye area and rinse thoroughly with lukewarm water. Do not use on face.

  • DOSAGE & ADMINISTRATION

    Wet Skin. Apply scrub on face and gently massage except eye area and rinse thoroughly with lukewarm water. Do not use on face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PLU BODY SCRUB PRESTIGE SILK EDITION 
    glycerin body scrub lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71503-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin6.84 g  in 180 mL
    Inactive Ingredients
    Ingredient NameStrength
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Adansonia Digitata Seed Oil (UNII: 77MKL7AR5I)  
    Disodium Lauroyl Glutamate (UNII: O99ROV57IA)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71503-005-01180 mL in 1 PACKAGE; Type 0: Not a Combination Product07/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/13/2017
    Labeler - Zivon Cosmetic Co., Ltd. (693893738)
    Registrant - Zivon Cosmetic Co., Ltd. (693893738)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zivon Cosmetic Co., Ltd.693893738manufacture(71503-005)