Label: REVITEALIZE ANTI DANDRUFF- salicylic acid shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 24, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Salicylic Acid 1.8%

  • PURPOSE

    Purpose: 

    Help Control of flaking and itching associated with dandruff
  • INDICATIONS & USAGE

    Uses:

    For relief of itching and scalp flaking associated with dandruff, seborrheic dermatitis and psoriasis.
  • WARNINGS

    Warnings:

    • For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of small children. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
  • ASK DOCTOR

    If swallowed, get medical help or contact a Poison Control Center immediately. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.



  • DOSAGE & ADMINISTRATION

    Directions
    For best control of dandruff, use every time you shampoo. Wet hair, massage shampoo onto scalp, wait for at least 2 minutes, rinse, repeat if necessary.
    For best results use at least twice a week or as directed by a doctor
  • INACTIVE INGREDIENT


    Inactive Ingredients
    Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Stach Hydroxypropyltrimonium Chloride, Glycerol Laurate, Green Tea Leaf Extract, SD Alcohol 40 (Alcohol Denatured), Aloe barbadensis Leaf Juice, Polysorbate 20, Glycerin, Panthenol, Retinyl Palmitate, Cholecalciferol, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Zea Mays (Corn) Oil, Tetrasodium EDTA, DMDM Hydantoin.





  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    REVITEALIZE  ANTI DANDRUFF
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54866-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid18 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CORN OIL (UNII: 8470G57WFM)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54866-000-01250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/01/2011
    Labeler - Camellix, LLC (968429386)
    Registrant - RAANI CORPORATION (067084681)
    Establishment
    NameAddressID/FEIBusiness Operations
    RAANI CORPORATION067084681manufacture
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