Label: CONTROL DANDRUFF- FREE BEARD WASH- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione Zinc 1.0%

  • Purpose

    Anti-Dandruff

  • Use

    Helps eliminate flaking, itching and scaling associated with dandruff and seborrheic dermatitis

  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

    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

    • If swallowed, get medical help or contact a Poison Control Center right away.
    • If condition covers a large area of the body, consult your doctor before using this product.
  • Directions

    • adults and children 3 years of age and older:
      • apply to wet beard or hair
      • gently massage into beard, hair and scalp and leave for 2-3 minutes before thoroughly rinsing.
      • rinse and repeat if desired
      • for best results use at least twice a week or as directed by your doctor
  • Inactive ingredients

    ammonium laureth sulfate, water, ammonium lauryl sulfate, cocamidopropyl betaine, sodium lauroyl sarcosinate, soapberry (Sapindus mukurossi) fruit extract, salicylic acid, salt (sodium chloride), polyquaternium-10, sodium benzoate, triethanolamine, fragrance

  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton

    Kamedis®
    Skin Restoring Solutions

    BOTANIPLEX
    TECHNOLOGY

    CONTROL
    Dandruff Free
    Beard Wash

    PYRITHIONE ZINC 1%
    Prevents and fights beard flaking.
    Relieves irritation redness and
    itchiness associated with dandruff.
    Leaves the beard shiny and smooth

    DERMATOLOGIST
    RECOMMENDED
    Free from Parabens, Steroids,
    Dyes, Sodium Lauryl Sulfate, Tar

    200 mL
    6.7 fl oz

    PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CONTROL DANDRUFF- FREE BEARD WASH 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50718-0035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0035-11 in 1 CARTON12/01/2022
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03212/01/2022
    Labeler - Kamedis Inc (080311300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biogenesis Inc069117328MANUFACTURE(50718-0035)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc793406000MANUFACTURE(50718-0035)
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