Label: BAEKNYONDONGAN TREATMENT- witch hazel solution

  • 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 May 30, 2012

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  • ACTIVE INGREDIENT

    Active ingredient: WITCH HAZEL 0.1%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Perilla Ocymoides Leaf  Extract, Oryza Sativa (Rice) Extract, Butylene Glycol, Glycerin, Steartrimonium Chloride, Cyclopentasiloxane, Dimethiconol, Stearyl Alcohol, Cetyl Alcohol, Polyquaternium-7, Cyclohexasiloxane, Hydroxyethyl cellulose, Perfume, Betaine, Methylparaben, Tocopheryl Acetate, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Panthenol, Sophora Angustifolia Root Extract, Ubiquinone, Hydrolyzed keratin

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:
    For external use only.
    Do not use on wounds of if you are allergic to any ingredients of this product.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep away from children.

  • INDICATIONS & USAGE

    Indication and usage:
    Towel dry your hair after shampooing.
    Apply adequate amount of treatment to the hair and leave it for 5-10 minutes before rinsing.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take appropriate amount according to your hair condition and use it every day.

  • PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    BAEKNYONDONGAN TREATMENT 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54948-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.55 mL  in 550 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYL OCTADECYL AMMONIUM CHLORIDE (UNII: CZ70647U92)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BETAINE (UNII: 3SCV180C9W)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54948-100-01550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/03/2011
    Labeler - MIX & MATCH CO., LTD. (689898943)
    Registrant - MIX & MATCH CO., LTD. (689898943)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIX & MATCH CO., LTD.689898943manufacture
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