Label: ROOTA RE V TONIC - panthenol liquid

  • 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), rosa centifolia flower water, sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, methylparaben, , dipotassium glycyrrhizate, hydrolyzed soybean protein, carmellia sinensis leaf extract, , 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, ficus carica fruit extract, morus alba fruit extract, fragrance
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  • PURPOSE

    hair care
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  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
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  • INDICATIONS & USAGE

    after shampooing, dry your hair and sclap thoroughly
    apply the tonic into scalp and gently massage with fingertips to help absorption

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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 TONIC 
    panthenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54576-4001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FICUS CARICA WHOLE (UNII: MAW09HMQ3X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
    GINKGO (UNII: 19FUJ2C58T)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54576-4001-1 100 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(54576-4001)
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