Label: LANCELL HUITOMO HAIR LOSS PREVENTION HAIR GROWER CLEAN FORMULA- pyrithione zinc 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 December 1, 2014

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  • ACTIVE INGREDIENT

    zinc pyrithion


  • INACTIVE INGREDIENT

    ■ Purified water ■Ammonium laureth sulfate ■Ammonium lauryl sulfate ■Cocamidopropyl betaine ■Poly(oxyethylene) methylpoly siloxane copolymer ■Sophora flavescens root extract ■Dexpanthenol ■Cerium nitrate(III) 6-hydrate ■Coix lacryma-jobi ma-yuen seed extract ■Sodium citrate ■Citric acid ■Jojoba oil ■Disodium EDTA ■Glycyrrhiza glabra (licorice) root extract ■Sodium methyl parahydroxybenzoate ■Methylchloroisothiazolone and methylisothiazolone mixture ■Flavor



  • PURPOSE

    scalp protectant (hair growth and loss prevention)


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    ■ Apply only scalp
    ■ Apply once a day before go to bed each one 6 ~ 8ml
    ■ Massage with your finger over 2 min or wait over 3 min before rinse the clean formula out of your head



  • WARNINGS

    For external use only, drinking ban
    When using this product
    ■ keep out of eyes, ears, and mouth. If contact occurs, rinse with plenty of worm or cold water right away and in a serious situation, contact a physician. If swallowing, drink plenty of water and contact a physician
    ■ Keep out of reach of the children



  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    LANCELL HUITOMO HAIR LOSS PREVENTION HAIR GROWER CLEAN FORMULA 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69388-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BIOTIN (UNII: 6SO6U10H04)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69388-1001-1300 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/01/2014
    Labeler - Lancell Bio Co., Ltd. (689062337)
    Registrant - Lancell Bio Co., Ltd. (689062337)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lancell Bio Co., Ltd.689062337manufacture(69388-1001)