Label: BIOXSINE SERIES- pyrithione zinc 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 December 5, 2011

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  • ACTIVE INGREDIENT

    Pyrithione Zinc 1.5%

  • PURPOSE

    Antidandruff

  • INDICATIONS & USAGE

    Helps eliminate and reduces the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff.

  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply a tablespoon of shampoo to wet hair and gently massage the scalp with fingertips for 1.5 to 2 minutes and rinse well
    • for best results use at least twice a week or as directed by a doctor
  • STORAGE AND HANDLING

    Store away from direct sunlight

  • INACTIVE INGREDIENT

    Cosmetic Ingredients Acrylates Copolymer, Amodimethicone, Apigenin, Benzyl Alcohol, Biocomplex B11 Herbal Extract [Achillea Millefolium Extract], Ceratonia Siliqua (Carob) Fruit Extract, Chamomilla Recutita (Matricaria) Flower Extract, Equisetum Arvense Extract, Urtica Dioica (Nettle) Root Extract, Urtica Urens Leaf Extract, Biotinoyl Tripeptide-1, Butylene Glycol, C11-15 Pareth-7, Citric Acid, Citronellol, Cocamidopropyl Betaine, Fragrance, Geraniol, Glycerin, Hydroxypropyl Guar Hydroxyproplytrimonium Chloride, Laureth-2, Laureth-9, Mel, Methylchloroisothiazolinone, Methylisothiazolinole, Oleanolic Acid, Panthenol, PEG-40 Hydrogenated Castor Oil, PEG/PPG-120/10 Trimethylpropane Trioleate, Polysorbate 20, PPG-26-Buteth-26, Propylene Glycol, Salicylic Acid, Sodium Chloride, Sodium Laureth Sulfate, Trideceth-12, Vitis Vinifera (Grape) Seed Extract, Water


  • QUESTIONS

    Toll Free 1-855-246-8291 Monday through Friday, 9am-5pm

  • DESCRIPTION

    B'IOTA Botanicals Dandruff Shampoo

    Benefits

    • Dermatologist tested
    • For women and men
    • No known side effects
    • Safe for color-treated hair
    • Revitalizes the appearance of hair and provides volume, shine and vibrancy
    • Eliminates and reduces the recurrence of the symptoms of dandruff

    Distributed by:
    B'IOTA Botanical Laboratories
    2 Greenwich Office Park, Suite 300
    Greenwich, CT 06830

    Product of Turkey

    www.biotabotanicals.com
    Toll Free 855-246-8291
  • PRINCIPAL DISPLAY PANEL

    Shampoo Carton

  • INGREDIENTS AND APPEARANCE
    BIOXSINE SERIES  
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23637-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC4.5 mL  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    APIGENIN (UNII: 7V515PI7F6)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    CAROB (UNII: 5MG5Z946UO)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    URTICA DIOICA ROOT (UNII: J8HE8A6E5T)  
    URTICA URENS LEAF (UNII: 0DCW2P163M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GERANIOL (UNII: L837108USY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-2 (UNII: D4D38LT1L5)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    HONEY (UNII: Y9H1V576FH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23637-001-011 in 1 CARTON
    1300 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/2012
    Labeler - B'IOTA Laboratories (968738240)
    Registrant - B'IOTA Laboratories (968738240)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S566215073manufacture
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