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

  • NDC Code(s): 52261-1400-1
  • Packager: Cosco International, Inc.
  • 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 December 1, 2022

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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

  • 266ml NDC: 52261-1400-1

    266ml 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/01/2022
    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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