Label: ROOTA RE V TONIC - panthenol liquid 

  • 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

If you are a consumer or patient please visit this version.

  • 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 LABEL Item Code (Source) NDC:54576-4001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PANTHENOL (PANTHENOL) PANTHENOL 0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    BUTYLENE GLYCOL  
    POLYOXYL 40 HYDROGENATED CASTOR OIL  
    POLYSORBATE 80  
    UREA  
    MENTHOL  
    SALICYLIC ACID  
    ROSA CENTIFOLIA FLOWER  
    GLYCYRRHIZINATE DIPOTASSIUM  
    METHYLPARABEN  
    .ALPHA.-TOCOPHEROL ACETATE  
    SOY PROTEIN  
    ALLANTOIN  
    SODIUM CITRATE  
    ROSA CANINA FRUIT OIL  
    EDETATE DISODIUM  
    FICUS CARICA WHOLE  
    NIACINAMIDE  
    PYRIDOXINE HYDROCHLORIDE  
    SOPHORA FLAVESCENS ROOT  
    ACORUS CALAMUS ROOT  
    GINKGO  
    MORUS ALBA BARK  
    GLYCYRRHIZA GLABRA  
    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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