Label: VERSION X SCALP TONIC- allantoin 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 May 21, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water,SD Alcohol 40-B,Butylene Glycol,Nonoxynol-12,Propylene Glycol,Panthenol,Fragrance,0.3H0.1ydrolyzed Soy Protein,DMDM Hydantoin,Menthol,Peg-60 Almond Glycerides,Hair Keratin, Amino Acids,Sodium Chondroitin Sulfate,3-Aminopropane Sulfonic Acid,Chlorphenesin, Xantham Gum,PG-Propyl Silanetriol,Hydrolyzed Wheat Protein,Ethyl Nicotinate,Benzophenone-4, Sodium PCA,Yellow 6 (CI 15985),Red 40 (CI 16035),Blue 1 (CI 42090),Sodium Chloride,Disodium EDTA,Alcohol,Cetyl Triethylmonium Dimethicone PEG-8phthalate,Ginkgo Biloba Leaf Extract,Swertia Japonica Extract,Laminaria Digitata Extract,Pelvetia Canaliculata Extract,Anacyclus Pyrethrum, Root Extract,Beta Vulgaris (Beet) Root Extract,Adiantum Pedatum Extract,Flower Extract, Eugenia Caryophyllus (Clove),Hedychium CoronariumRoot Extract,Arnica Montana Flower Extract, Urtica Dioica (Nettle) Extract,Rosmarinus Officinalis(Rosemary) Leaf Extract,Shell Extract,Juglans Nigra(Black Walnut),Salvia Officinalis (Sage) Leaf Extract, Hamamelis Virginiana,Quillaja Saponaria Bark Extract,Algae Extract,Phytantriol,Biotin,Niacin,Retinyl Palmitate, Tocopheryl Nicotinate

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    CAUTION:
    For external use only.
    Avoid eye contact.
    Keep out of reach children.
    In case of accidental ingestion, seek professional attention immediately.
    Some redness and iffitation of the scalp is nomal

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS AND USAGE

    DIRECTIONS
    Apply directly to clean, towel-dried scalp.
    Spray the stimulant to the affected and surrounding areas of the scalp once daily.
    Gently massage the stimulant into the scalp for 10-20 seconds.
    Do not wash or rinse hair for at least three hours. For best results continue use on a daily basis.

  • DOSAGE AND ADMINISTRATION

    DIRECTIONS
    Apply directly to clean, towel-dried scalp.
    Spray the stimulant to the affected and surrounding areas of the scalp once daily.
    Gently massage the stimulant into the scalp for 10-20 seconds.
    Do not wash or rinse hair for at least three hours. For best results continue use on a daily basis.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    VERSION X SCALP TONIC 
    allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58069-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.625 mg  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Panthenol (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58069-010-01125 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2013
    Labeler - CHRISTLTD (557806035)
    Registrant - CHRISTLTD (557806035)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHRISTLTD557806035manufacture(58069-010)