Label: ROOTHOUSE ENCORE- salicylic acid, dexpanthenol, l-menthol shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 26, 2016

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  • ACTIVE INGREDIENT

    Salicylic Acid, Dexpanthenol, L-Menthol

  • INACTIVE INGREDIENT

    Water, Dimethicone, Perilla Frutescens Leaf (Perilla Ocymoides Leaf), and Thuja Orientalis Leaf, etc.

  • PURPOSE

    Prevent hair loss and increase hair thickness.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out or reach of the children

  • INDICATIONS & USAGE

    After getting hairs wet enough with clean water, apply as needed and make some foam from the almost scalp, and then shampoo as if massaging. When there is plenty of foam, leave it as it is 1-2 minutes. After that, wash hairs well with clean water.

  • WARNINGS

    1. If rash, flare, itching, and other symptoms are caused by the treatment, then stop using it and contact a medical doctor or a pharmacist.
    2. Do not apply on skin regions with damage, eczema and dermatitis.
    3. If it goes in the eyes, immediately clean the eyes.
    4. Attention in storage

    1) Close the lid after use.

    2) Keep it away from the touch of young children.

    3) Keep out of high temperature, low temperature, and direct sunlight.

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ROOTHOUSE ENCORE 
    salicylic acid, dexpanthenol, l-menthol shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70652-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70652-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2016
    Labeler - Roothouse (688709975)
    Registrant - Roothouse (688709975)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roothouse688709975manufacture(70652-0001)
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