Label: FLAKES CEDAR MINT ANTI DANDRUFF- pyrithione zinc lotion/shampoo

  • NDC Code(s): 52261-1400-1, 52261-1400-2
  • Packager: Cosco International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 21, 2024

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  • DRUG FACTS

    Active Ingredients:                  Purpose:

    Pyrithione Zinc 2%..................Anti dandruff

  • PURPOSE

    Use:  For the control of the symptoms of dandruff and or seborrheic dermatitis

  • WARNINGS

    Warnings

    for external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • WHEN USING

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

  • INDICATIONS & USAGE

    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 best results, use at least twice a week or as directed by a doctor.
    • Wet hair thoroughly
    • Massage a liberal amount into your scalp
    • Leave lather on scalp for several minutes
    • Rinse and repeat.

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCO MONOETHANOLAMIDE, FRAGRANCE, GLYCERIN, PHENOXYETHANOL, PEPPERMINT OIL, HYDROXYPROPYL GUAR, HYDROXYPROPYL TRIMONIUM CHLORIDE, CAPRYLYL GLYCOL, POLYACRYLATE CROSSPOLYMER-6, METHYL DIISOPROPYL PROPIONAMIDE, TEA TREE OIL, CITRIC ACID

  • QUESTIONS

    Questions?

    help@byeflakes.com

  • STORAGE AND HANDLING

    Other Information
    Store at room temperature between 68-77°F (20-25°C).
    Do not expose to excessive heat

  • PRINCIPAL DISPLAY PANEL

    266ml label

  • PRINCIPAL DISPLAY PANEL

    85ml label

  • INGREDIENTS AND APPEARANCE
    FLAKES CEDAR MINT ANTI DANDRUFF 
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-1400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.02 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-1400-10.266 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
    2NDC:52261-1400-20.085 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03212/01/2022
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-1400) , label(52261-1400) , pack(52261-1400)
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