Label: ROOTA RE V TONIC- panthenol liquid

  • Category: HUMAN OTC DRUG LABEL

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 December 31, 2012

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  • ACTIVE INGREDIENT

    panthenol
  • INACTIVE INGREDIENT

    Aqua (Water), rosa centifolia flower water, sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, methylparaben, , dipotassium glycyrrhizate, hydrolyzed soybean protein, carmellia sinensis leaf extract, , allantoin, sodium citrate, zinc sulfate, disodium edta, rosemary leaf oil, niacinamide, panax ginseng root extract, pyridoxine hci, sophora angustifolia root extract, acorus calamus root extract, polygonum multiflorum root extract, morus alba bark extract, licorice root extract, ginkgo biloba leaf, ficus carica fruit extract, morus alba fruit extract, fragrance
  • PURPOSE

    hair care
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    after shampooing, dry your hair and sclap thoroughly
    apply the tonic into scalp and gently massage with fingertips to help absorption
  • WARNINGS

    stop use if irritation occurs


  • DOSAGE & ADMINISTRATION

    for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    ROOTA RE V TONIC 
    panthenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54576-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    UREA (UNII: 8W8T17847W)  
    MENTHOL (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FICUS CARICA WHOLE (UNII: MAW09HMQ3X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
    GINKGO (UNII: 19FUJ2C58T)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54576-4001-1100 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/31/2012
    Labeler - Raphabio Inc (688480119)
    Registrant - Raphabio Inc (688480119)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grace C&T688222810manufacture(54576-4001)
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