Label: ROOTA RE V FOR WOMEN - panthenol shampoo

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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  • ACTIVE INGREDIENT

    panthenol
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  • INACTIVE INGREDIENT

    Aqua (Water), Cocamide DEA, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betain, Glycerin, Tetrasodium EDTA, Zinc Pyrithion, Sodium Chloride, Sodium laureth sulfate, 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, cocamide DEA, Rosa centifolia flower water, sophora angustifolia root extract, polygonum multiflorum root extract, rosa canina fruit oil, hydrolyzed soybean protein, ficus carica fruit extract, fragrance
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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 V FOR WOMEN 
    panthenol shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54576-2001
    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)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
    FIG (UNII: TGD87RII2U)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GINKGO (UNII: 19FUJ2C58T)  
    UREA (UNII: 8W8T17847W)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CLOVE (UNII: K48IKT5321)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54576-2001-1 240 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(54576-2001)
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