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, Alcohol Denat., Linum Usitatissium,

    (Linseed) Seed Oil, Cetrimonium Chloride, Peg-40 Hydrogenated

    Castor Oil, Disodium Edta, Sodium Hydroxide, Fragrance

  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc 0,1 %

  • 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

    -Apply to affected areas one to four time daily or as directed by a doctor.

    -Firstly, wash the hair with anti-dandruff shampoo. Shake the phial well

    before use and then evenly apply the contents to the scalp.

    Gently massage in with the fingertips using an outward and inward motion

    or allow to absorb and, without rinsing, style the hair in the usual manner.

  • 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:59538-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC.1 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    FLAX SEED (UNII: 4110YT348C)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59538-003-036 in 1 CARTON08/01/2013
    160 g in 1 VIAL; 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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