Label: HAIRQ-PLUS- biotin solution

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

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Drug Label Information

Updated May 25, 2012

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  • ACTIVE INGREDIENT

    active ingredient: biotin
  • INACTIVE INGREDIENT

    inactive ingredient: niacinamide, water,copper tripeptide, zinc pyrithion, chamaecyparis, obtusa water,  sodium chloride, sodium metasilicate, sodium thiosulfate, sodium carbonate, sodium citrate, citric acid, tetrasodium EDTA
  • PURPOSE

    hair growth, hair loss prevention and scalp protectant
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    - apply only for scalp
    - apply 2 or 3 times a day with 5~6ml
    - massage with your finger over 2 min and let them dry


  • WARNINGS

    - keep out of eyes, ears and mouth
    - if contact occurs, rinse away with plenty of cold water
  • DOSAGE & ADMINISTRATION

    - for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    HAIRQ-PLUS 
    biotin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49658-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.06 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRITHIONE ZINC (UNII: R953O2RHZ5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49658-4001-1200 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/25/2012
    Labeler - Cresson (557816861)
    Registrant - Cresson (557816861)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cresson557816861manufacture
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