ROOTA RE F TONIC (PANTHENOL) LIQUID [RAPHABIO INC]

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ROOTA RE F TONIC (PANTHENOL) LIQUID [RAPHABIO INC]
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NDC 54576-3001-1
Set ID 3e00b36f-fe7b-4a17-98aa-6a53b1fadc7c
Category HUMAN OTC DRUG LABEL
Packager Raphabio Inc
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    panthenol
  • INACTIVE INGREDIENT

    Aqua (Water), sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, glycolic acid, dipotassium glycyrrhizate, camphor, tocopheryl acetate, peppermint oil, 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 extract, copper tripeptide-1
  • 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 F TONIC  
    panthenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54576-3001
    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)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ROSEMARY (UNII: IJ67X351P9)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
    FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GINKGO (UNII: 19FUJ2C58T)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54576-3001-1100 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(54576-3001)
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