Label: SAYAK- glycerin 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 January 30, 2014

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

  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    Luffa Cylindrica Stem Sap,Aqua, Sodium Laureth Sulfate, Glycerin,Cocamidopropyl Betaine,Butylene Glycol,1,2-Hexanediol,Sodium Cocoyl Glycinate, Angelica Dahurica Root Powder,Camellia Sinensis Leaf Powder, Citrus Unshiu Peel Powder,Cnidium Officnale Root Powder, Opuntia Coccinellifera Fruit powder, Scutellaria Baicalensis Root Powder,Houttuynia Cordata Powder, Chamaecyparis Obtusa Powder,Polygonum Multiflorum Root Powder, Portulaca Oleracea Powder,Sophora Flavescens Root Powder, Paeonia Albiflora Root Powder,Artemisia Princeps Leaf Powder, Glycyrrhiza Glabra (Licorice) Root Powder, Laminaria Japonica Powder,Poria Cocos Powder, Mentha Arvensis Powder,Pinus Densiflora Leaf Powder, Coptis Chinensis Root/Stalk Powder, Coix Lacryma-Jobi Ma-yuen Seed Powder, Phellodendron Amurense Bark Extract,Coptis Japonica Root Extract, Scutellaria Baicalensis Root Extract,Rheum Palmatum Root Extract, Arctium Lappa Root Extract,Houttuynia Cordata Extract, Chamaecyparis Obtusa Leaf Extract, Taraxacum Officinale (Dandelion) Rhizome/Root Extract, Polygonum Multiflorum Root Extract,Eclipta Prostrata Extract, Urtica Dioica (Nettle) Extract,Zanthoxylum Alatum Fruit Extract, Sciadopitys Verticillata Root Extract,Saururus Chinensis Extract, Taraxacum Platycarpum Extract,Paeonia Albiflora Root Extract, Opuntia occinellifera,Silkworm Extract,Sophora Angustifolia Root Extract, Lycium Chinense Fruit Extract,Prunella Vulgaris Extract, Alisma Orientale Tuber Extract,Gentiana Scabra Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Paeonia Suffruticosa Root Extract,Cnidium Monnieri Fruit Extract, Camellia Sinensis Leaf Extract,Asarum Sieboldi Root Extract, Cnidium Officinale Root Extract,Artemisia Princeps Leaf Extract, Angelica Gigas Root Extract,Glycyrrhiza Glabra (Licorice) Root Extract, Mentha Arvensis xtract,Angelica Dahurica Root Extract, Prunus Armeniaca (Apricot) Kernel Extract,Chaenomeles Sinensis Fruit Extract, Poria Cocos Extract,Citrus Unshiu Peel Extract,Polygonatum Odoratum Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract,Cuscuta Australis Seed Extract, Tribulus Terrestris Fruit Extract,Sigesbeckia Orientalis Extract, Mica,Smilax China Root Extract,Zanthoxylum Piperitum Fruit Extract, Laminaria Japonica Extract,Thuja Orientalis Seed Extract,Tocopheryl Acetate, Glechoma Hederacea Extract,Forsythia Koreana Branch/Leaf Extract, Euonymus Sachalinensis Bark Extract,Morus Alba Root Extract, Xanthium Strumarium Fruit Extract,Portulaca Oleracea Extract,Sodium Chloride, Citrus Limon (Lemon) Fruit Oil,Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf oil, Phenoxyethanol


  • PURPOSE

    to solve the various skin problems such as haggard skin, relax complexion, blackhead, pore tightening
    to remove demodex folliculorum the cause of skin troubles



  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    after coat some water on face 2-3 times, spread 3g of Sayak cream on face and rub evenly in 4 minutes
    rub strongly in first 1 minute and then rub softly in 3 minutes
    while using if you feel it is somewhat thick, add some more water on it which can make it rub smoothly
    after 4 minutes use, wash off


  • WARNINGS

    stop use if irritation occurs
    avoid contact with eyes


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    SAYAK 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61884-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TANGERINE (UNII: KH3E3096OO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61884-1001-210 in 1 BOX
    1NDC:61884-1001-13 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/30/2014
    Labeler - GMS (688688884)
    Registrant - GMS (688688884)
    Establishment
    NameAddressID/FEIBusiness Operations
    GMS 688688884manufacture(61884-1001)