Label: SPAI-SONS PROCAPELL- biotin liquid

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 7, 2012

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  • ACTIVE INGREDIENT

    Biotin is a major component of the formulation acts to strengthen the hair follicle and prevents hair loss as well. It is nutrient for the hair root and helps oxygenate the hair turn slowing the loss. Provides resilience and resistance to hair. Addition of biotin are other ingredient such as apigenin, biotinoyl tripeptide-1 and ginkgo extract which help strengthen the hair follicle and produce a synergistic action on it.

  • PURPOSE

    A biotechnological product that accelerates the cellular biodynamics to slow down hair loss.

    1. Delays the aging process of the capillary follicle and accelerates its growth

    2. Strengthens hair stem and stimulates hair growth

    3. Repairs and protects the structure of the hair follicle, prolonging hair life.

  • KEEP OUT OF REACH OF CHILDREN

    This product must be keep out reach of children

  • INDICATIONS & USAGE

    This product is for topical application directly on the hair follicle

  • WARNINGS

    Avoid contact with eyes, if they do wash with water. If swallowed contact a physician immediately

  • DOSAGE & ADMINISTRATION

    Recommended use: slow  down hair loss; accelerates growth and increments hair recovery.

    Directions: apply every 12 hours on scalp and acitivate tapping softly with fingertips.

  • INACTIVE INGREDIENT

    This is a liquid product prepared with the technology needed to  provide the hair follicle absorption of the active ingredients, plus inactive ingredients contribute to the regeneration of the hair fiber by providing a strengthening therefore. No adverse effects were seen with the use of this product as inactive ingredients  do not cause skin hypersensivity

  • PRINCIPAL DISPLAY PANEL


    IMAGE OF THE CARTON LABEL


    IMAGE OF THE CARTON LABEL

    IMAGE OF THE CARTON LABEL


  • INGREDIENTS AND APPEARANCE
    SPAI-SONS  PROCAPELL
    biotin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.01 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    APIGENIN (UNII: 7V515PI7F6)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROLYZED PLACENTAL PROTEIN (BOVINE) (UNII: KR5CS6RBH9)  
    ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)  
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-011-0170 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/30/2012
    Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack