KAEWOON (GLYCERIN, ALLANTOIN) GEL [RNCARE]

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KAEWOON (GLYCERIN, ALLANTOIN) GEL [RNCARE]
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NDC 71237-001-01, 71237-001-02
Set ID 516b9ebb-ee12-47c2-afc5-24c7094cca25
Category HUMAN OTC DRUG LABEL
Packager RNCARE
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Glycerin 3%

    Allantoin 0.2%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Body Cleansing

  • DOSAGE & ADMINISTRATION

    Take an appropriate amount and massage onto scalp/body for about 60 seconds and rinse with water

  • WARNINGS

    In case of eye contact, immediately rinse with water

    Stop use if unusual redness, swelling, soreness or irritation occur

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INACTIVE INGREDIENT

    Cocamide DEA, Oleic Acid, Lauramidopropyl Betaine, PEG-60 Castor Oil, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Shea Butteramidopropyl Betaine, Polysorbate 80, Water, Propylene Glycol, Sodium Cocoamphoacetate, Butylene Glycol, Capryl/Capramidopropyl Betaine, Lecithin, Curcuma Longa (Turmeric) Root Extract, Phaseolus Radiatus Seed Extract, Artemisia Vulgaris Extract, Arctium Lappa Root Extract, Hippophae Rhamnoides Extract, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Eucalyptus Globulus Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Panax Ginseng Root Extract, Propolis Extract, 6-Aminocaproic Acid, Polyquaternium, Disodium EDTA, Black Strap Powder, Hexanediol, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Hydroxyethylcellulose, Menthol, Citric Acid, Frageance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KAEWOON 
    glycerin, allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71237-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN30 mg  in 1 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PEG-60 CASTOR OIL (UNII: VXP26NM2XX)  
    RICE BRAN (UNII: R60QEP13IC)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    TURMERIC (UNII: 856YO1Z64F)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    CRATAEGUS LAEVIGATA FLOWER (UNII: 85EAT04F4H)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    AMINOCAPROIC ACID (UNII: U6F3787206)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HEXANEDIOL (UNII: ZIA319275I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71237-001-021 in 1 CARTON02/02/2017
    1NDC:71237-001-01320 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/02/2017
    Labeler - RNCARE (694893883)
    Registrant - RNCARE (694893883)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNCARE694893883manufacture(71237-001)
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