Label: TMC-A HAIR TONIC- oatmeal liquid

  • 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 July 11, 2014

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  • ACTIVE INGREDIENT

    oatmeal

  • INACTIVE INGREDIENT

    onion bulb ext, radish root ext, oenanthe javanica ext, porato pulp ext, carrot root ext, pear fruit ext, lemon fruit ext, nelumbo nucifera root ext, zanthoxylum schinifolium leaf ext, radish leaf ext, clove flower ext, artemisia vulgaris ext, pinus densiflora leaf ext, polygonum multiflorum root ext, chrysanthellum indicum ext, cnidium officinale root ext, eclipta prostrata ext, ginger root ext, camellia sinensis leaf ext, lycium chinense fruit ext, dodonopsis lancelolata root ext, laminaria japonica ext, saururus chinensis ext, thistle flower/leaf/stem ext, chrysanthemum sibiricum ext, panax ginseng leaf/stem ext, ginkgo biloba leaf ext, acorus calamus root ext, mentha arvensis ext, undaria pinnatifida ext, lysine, proline


  • PURPOSE

    nourishing and moisturizing hair


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    more than 3 times per a day, spread at the part of hair loss and softly massage
    shake well before use


  • WARNINGS

    do not use on damaged or broken skin
    when using this product keep out of eyes rinse with water to remove
    stop use and ask a doctor if rash occurs
    do not swallow


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    TMC-A HAIR TONIC 
    oatmeal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69100-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.0001 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ONION (UNII: 492225Q21H)  
    RADISH (UNII: EM5RP35463)  
    LYSINE (UNII: K3Z4F929H6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69100-1001-1150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/11/2014
    Labeler - Gahwa Well Food Co.,Ltd (557832986)
    Registrant - Gahwa Well Food Co.,Ltd (557832986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eurocostech Co,. Ltd.689909208manufacture(69100-1001)