Label: CARIONE RG- zinc pyrithione, panthenol, niacinamide, biotin shampoo

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 23, 2016

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  • ACTIVE INGREDIENT

    Zinc Pyrithione, Panthenol, Niacinamide, Biotin

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Butylene Glycol, etc.

  • PURPOSE

    For hair and scalp care

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    Apply a quarter-sized amount of shampoo to the wet hair and gently massage your scalp usinng your finger tip.

  • WARNINGS

    1. Discontinue use and consult a doctor in case of allergic reaction.
    2. Do not use this product if you have an allergic disease.
    3. In case of getting it into eyes, washing it immediately.
    4. Keep out of the reach of infants or children.
    5. Keep lids on products when not in use and use the product wihin the recommended time.

    Storage: Store in a cool, dry place, away from direct sunlight and with the lids firmly close.

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    l

  • INGREDIENTS AND APPEARANCE
    CARIONE RG 
    zinc pyrithione, panthenol, niacinamide, biotin shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71039-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.3 g  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.5 g  in 100 mL
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 mL
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.06 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71039-0001-1300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/31/2016
    Labeler - Cell Activation Research Institute Co., Ltd (688258649)
    Registrant - Cell Activation Research Institute Co., Ltd (688258649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cell Activation Research Institute Co., Ltd688258649label(71039-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    HP&C,Ltd.689847430manufacture(71039-0001)