Label: SUYAN JEONGDAN- tea tree oil soap

  • 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 12, 2011

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  • drug facts

    Active ingredient
    Melaeuca Alternifolia(Tea Tree) Leaf Oil   0.50%

    Purpose

    Antiseptic

    Keep out of Reach of Children

    Keep out of reach of children
    if swallowed, get medical help or contact a Poison Control Center right away

    Indication & Usage

    Directions
    ■ Wet face, apply soap.
    ■ Make enough foam and scrub face.
    ■ Wash vigorously for at least 10 seconds
    ■ Rinse with water until all cleaner is removed from face.
    ■ Children must be supervised in use of this product

    Warnings

    Warnings
    For external use only.

    Do not use on Deep wounds, serious burns.
    When using this product avoid contact with eyes. In case of eye contact, flush with water for 15 minutes.
    Stop use and ask a doctor if rash, itching or irritation develops and lasts.

    Dosage & Administration

    For face washing to decrease bacteria on the skin.

    Inactive Ingredient

    Soap Base(Sodium Rosinate, Water, Sodium Chloride, Glycerin, Terasodim Etidronate, Tetrasodim EDTA), Eugeniacaryophyllus(Clove) Flower Extract, Silkworm Extract, Ipomoea Purpurea Extract, Tribulus Terrestris Fruit Extract, Bletilla Striata Root Extract, Angelica Dahurica Root Extract, Poria Cocos Root extract, Phaseolus Radiatus Extract, Unshiu oil, Simmondsia Chinensis(Jojoba) Seed Oil, Aloe Barbadensis Leaf Extract, Eriocephalus Punctulatus Oil, Tocopherol, Phytosqualane, Vitis Vinifera(Grape)Seed Oil, Ampelopsis japonica Root Extract, Acorus Gramineus Root/Stem Extract, Prunus Armeniaca(Apricot)Kernel Extract, Artemisia Vulgaris Extract, Sophora Angustifolia root Extract, Silkworm Extract, Ginkgo biloba Leaf Extract, Mentha Arvensis Extract, Phaseolus radiatus Seed Extract Vigna Radiata Seed Extract, Cnidium Officinale Root Extract

  • SUYAN JEONGDAN

    SUYAN JEONGDAN SOAP
    Net WT.  3.53 OZ (100g)

    image of carton label

  • INGREDIENTS AND APPEARANCE
    SUYAN JEONGDAN 
    tea tree oil soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76173-1008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CLOVE (UNII: K48IKT5321)  
    IPOMOEA PURPUREA TOP (UNII: XMQ0V9812O)  
    TRIBULUS TERRESTRIS FRUIT (UNII: QNL076V6EQ)  
    BLETILLA STRIATA BULB (UNII: 00T5SH6SEJ)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    AMPELOPSIS JAPONICA ROOT (UNII: O2672197TF)  
    ACORUS GRAMINEUS ROOT (UNII: Z60N6Q6E19)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    GINKGO (UNII: 19FUJ2C58T)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
    Product Characteristics
    Coloryellow (black) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76173-1008-1100 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/12/2011
    Labeler - Cellinbio Co Ltd (557803737)
    Registrant - Cellinbio Co Ltd (557803737)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cellinbio Co Ltd557803737relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanil Moolsan Co Ltd689009454manufacture