Label: ROOTA RE F FOR MEN - panthenol shampoo

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

Drug Label Information

Updated 12/12

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  • ACTIVE INGREDIENT

    panthenol
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  • 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
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  • PURPOSE

    hair care
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  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children
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  • INDICATIONS & USAGE

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

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  • WARNINGS

    stop use if irritation occurs


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  • DOSAGE & ADMINISTRATION

    for external use only
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  • INGREDIENTS AND APPEARANCE
    ROOTA RE F FOR MEN  
    panthenol shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54576-1001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 1.2 mg  in 240 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54576-1001-1 240 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/31/2012
    Labeler - Raphabio Inc (688480119)
    Registrant - Raphabio Inc (688480119)
    Establishment
    Name Address ID/FEI Business Operations
    Grace C&T 688222810 manufacture(54576-1001)
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