Label: TMC-A ANTI HAIRLOSS- glycerin shampoo

  • 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

    glycerine

  • INACTIVE INGREDIENT

    d.i water, biotin, nicotinamide, d-panthenol, zinc pyrithione liquid (48%), ammonium laureth sulfate (28%), ammonium lauryl sulfate (28%), edta-2na, methyl paraben, cocamide dea, cocamidopropyl betaine, l-menthol, methylchloroisothiazolinone/methylisothiazolinone, triethanolamine, polyquaternium-10, cabomer, eucalyptus ext, licorice root ext, camellia sinensis leaf ext, acorus calamus root ext, cnidium officinale root ext, artemisia vulgaris ext, chrysanthemum morifolium flower ext, rosemary ext, polygonum multiflorum root ext


  • PURPOSE

    for hair grower and hair loss prevention


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    shampoo everyday (1 time) as follows

    1) moisten hair and scalp enough with lukewarm water
    2) apply a moderate amount on your palm and massage hair and scalp gently
    3) after 2~3 minutes, rinse throughly with running warm water


  • 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 ANTI HAIRLOSS 
    glycerin shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69100-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69100-2001-1300 g 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
    AD Cosmetics Co., Ltd.688155662manufacture(69100-2001)
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