ROOTA RE F FOR MEN (PANTHENOL) SHAMPOO [RAPHABIO INC]

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ROOTA RE F FOR MEN (PANTHENOL) SHAMPOO [RAPHABIO INC]
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NDC 54576-1001-1
Set ID 889fb3cb-5a68-483b-aae7-e6e3957821eb
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), Sodium Laureth Sulfate, Cocamide DEA, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betain, Glycerin, Tetrasodium EDTA, Zinc Pyrithion, Sodium Chloride, Glyceryl Distearate, Menthol,Polyquarternium-10, Mentha Piperita (Peppermint) oil, Salicylic Acid,Cetyl Alcohol, Allantoin,Citric Acid,Zinc Sulfate,Disodium EDTA,Rosmarinus Officinalis (Rosemary) Leaf Oil, Pyridoxine HCl,Sophora Angustifolia Root Extract,Acorus Calamus Root Extract  ,Polygonum Multiflorum Root Extract, Morus Alba Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract  ,Ginkgo Biloba Leaf Extract, Urea,Niacinamide,Sodium Hydroxide,Copper Tripeptide-1,Methylchloroisothiazolinone, Methylisothiazolinone
  • PURPOSE

    hair care
  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children
  • INDICATIONS & USAGE

    1. apply sufficient quantity to intended part
    2. scrub softly as like doing massage
  • WARNINGS

    stop use if irritation occurs


  • DOSAGE & ADMINISTRATION

    for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    ROOTA RE F FOR MEN  
    panthenol shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54576-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL1.2 mg  in 240 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PYRITHIONE ZINC (UNII: R953O2RHZ5)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ROSEMARY (UNII: IJ67X351P9)  
    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)  
    UREA (UNII: 8W8T17847W)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54576-1001-1240 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(54576-1001)
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