Label: ROOTA RE V FOR WOMEN - panthenol shampoo 

  • Label RSS
  • 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 LABEL Item Code (Source) NDC:54576-2001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PANTHENOL (PANTHENOL) PANTHENOL 1.2 mg  in 240 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    COCO DIETHANOLAMIDE  
    SODIUM LAUROYL SARCOSINATE  
    COCAMIDOPROPYL BETAINE  
    GLYCERIN  
    EDETATE SODIUM  
    PYRITHIONE ZINC  
    SODIUM CHLORIDE  
    SODIUM LAURETH SULFATE  
    GLYCERYL DISTEARATE  
    MENTHOL  
    ROSA CENTIFOLIA FLOWER OIL  
    SALICYLIC ACID  
    CETYL ALCOHOL  
    ALLANTOIN  
    CITRIC ACID MONOHYDRATE  
    SOPHORA FLAVESCENS ROOT  
    EDETATE DISODIUM  
    FALLOPIA MULTIFLORA ROOT  
    ROSA CANINA FRUIT OIL  
    SOY PROTEIN  
    ACORUS CALAMUS ROOT  
    FIG  
    MORUS ALBA BARK  
    GLYCYRRHIZA GLABRA  
    GINKGO  
    UREA  
    NIACINAMIDE  
    SODIUM HYDROXIDE  
    CLOVE  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    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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