Label: BIOKERA- pyrithione zinc lotion/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 July 2, 2016

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Propylene Glycol. Cetyl Alcohol,

    Glycerin, Cetrimonium Chloride, Cyclopentasiloxane, Linum Usitattisium

    (Linseed) Seed oil, Amomethicone,

    Polyquaternum 11, Salicylic Acid, Citric Acid,

    Diazolidinyl Urea, Disodium Edta, Trideceth 12, Sodium Hydroxide,

    Iodopropynyl Butylcarbamate, Fragrance


  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc 0,5 %

  • PURPOSE

    Purpose

    Anti-dandruff

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of

    reach of children.

    If swallowed, get medical help or contact a Poison Control

    Center right away

  • INDICATIONS & USAGE

    Uses helps prevent recurrence of flaking and itching

    associated with dandruff


  • WARNINGS

    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

  • DOSAGE & ADMINISTRATION

    Directions

    -For the best results use at least twice a week or as directed

    by a doctor.

    -After washing, apply the product to the hair without

    touching the scalp. Comb to distribute evenly and leave in to act for a few

    minutes. Rinse with warm water and proceed to styling.


  • QUESTIONS

    Questions or comments?

    www.salerm.com -  0034 93 860 81 11

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    BIOKERA  
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59538-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC.5 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59538-002-021 in 1 CARTON08/01/2013
    1196 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/01/2013
    Labeler - SALERM COSMETICA PROFESIONAL, S.A. (563418532)
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