Label: CONTROL DANDRUFF THERAPY- dandruff therapy shampoo shampoo

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

Drug Label Information

Updated December 18, 2023

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  • 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 hair 
    •    gently massage into 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

  • SPL UNCLASSIFIED SECTION

    Made in USA
    (US and non US ingredients) Manufactured for
    Kamedis Pennsylvania, 18109.

    www.kamedis.com

  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton

    Kamedis®
    Skin Restoring Solutions

    BOTANIPLEX
    TECHNOLOGY

    SCALP
    CONTROL
    Dandruff Therapy
    Shampoo

    PYRITHIONE ZINC 1%

    Clinically proven to remove up to
    100% visible dandruff. Helps eliminate
    flaking, scaling, itching, irritation and
    redness associated with dandruff

    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 THERAPY 
    dandruff therapy shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50718-0021
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50718-0021-11 in 1 CARTON01/01/2018
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50718-0021-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03201/01/2018
    Labeler - Kamedis (080311300)
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