Label: SPAI-SONS PROLAC-VIT- biotin liquid

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

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Drug Label Information

Updated August 5, 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 oxygenate the hair turn slowing the loss. Provides resilience and resistence to hair. Addition of biotin are other ingredient such as Asian Ginseng, Arginine, Zinc Gluconate, Niacinamide, Ornitine HCl, and Citrulline which help strengthen the hair follicle and produce a synergistic action on it.

  • PURPOSE

    Prolac-vit is a well balanced formula that helps the function and nutrition of hair root, resulting in abundant hair and neutralizing alopecia caused by lack and certain components, mistreatment or toxic agents.

  • 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: thin or fragile, ill-treated hair, malnourished scalp or hair roots, Alopecia, hair loss due to cycle change.

    Directions: must be applied directly to the scalp and then massage very gently until the product is absorbed

  • INACTIVE INGREDIENT

    This is a liquid 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 CARTON LABEL IMAGE OF CARTON LABEL

  • INGREDIENTS AND APPEARANCE
    SPAI-SONS  PROLAC-VIT
    biotin liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66854-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.01 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    ARGININE (UNII: 94ZLA3W45F)  
    N-ACETYL-TYROSINE (UNII: DA8G610ZO5)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    THREONINE (UNII: 2ZD004190S)  
    SERINE (UNII: 452VLY9402)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    GLYCINE (UNII: TE7660XO1C)  
    ALANINE (UNII: OF5P57N2ZX)  
    VALINE (UNII: HG18B9YRS7)  
    METHIONINE (UNII: AE28F7PNPL)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    LEUCINE (UNII: GMW67QNF9C)  
    TYROSINE (UNII: 42HK56048U)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    HYDROXYLYSINE (UNII: 2GQB349IUB)  
    ORNITHINE (UNII: E524N2IXA3)  
    LYSINE (UNII: K3Z4F929H6)  
    HISTIDINE (UNII: 4QD397987E)  
    ARGININE (UNII: 94ZLA3W45F)  
    TRYPTOPHAN (UNII: 8DUH1N11BX)  
    CYSTINE (UNII: 48TCX9A1VT)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH)  
    CITRULLINE (UNII: 29VT07BGDA)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMNIOTIC FLUID (BOVINE) (UNII: P06X62O7E9)  
    HYDROLYZED PLACENTAL PROTEIN (BOVINE) (UNII: KR5CS6RBH9)  
    WHEAT GERM (UNII: YR3G369F5A)  
    POLYQUATERNIUM-39 (35/35/30 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW) (UNII: EOD3UE785A)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SULFUR (UNII: 70FD1KFU70)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-007-0170 mL in 1 BOTTLE
    2NDC:66854-007-0210 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/06/2012
    Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184manufacture(66854-007) , analysis(66854-007) , label(66854-007) , pack(66854-007)
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