Label: ALEVAI - STEM CELL ANTI DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 81457-020-04, 81457-020-08, 81457-020-16, 81457-020-32
  • Packager: ALEVAI PRODUCTS LLC
  • 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 14, 2022

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  • ACTIVE INGREDIENT

    Pyrithione Zinc………………………………………………………………………………………. 2% Anti-dandruff

  • PURPOSE

    Use helps prevent recurrence of flaking and itching associated with dandruff.

  • INDICATIONS & USAGE

    When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Shake well. Wet hair. Massage shampoo into scalp. Rinse. Repeat if desired. For best results, use at least twice a week or as directed by a doctor. For maximum dandruff control, use every time you shampoo.

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

  • INACTIVE INGREDIENT

    Aqua, Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Methyl Gluceth-20, Cocamide MEA, Caprylyl Glycol, Hexylene Glycol, Parfum, Sodium Hydroxide, Polyquaternium-7, Mica, Titanium Dioxide, Silica, Iron Oxide, Tin Oxide, Propylene Glycol, Biotin, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Sodium Benzoate, Camellia Sinensis Leaf Extract, Disodium EDTA, Hydrolyzed Keratin, Citric Acid, Panthenol, Argania Spinosa Kernel Oil, Cocos Nucifera Oil, Phenoxyethanol, FD&C Blue. 1 (CI 42090), Hexyl Cinnamal, Citral.

  • ALEVAI - ANTI DANDRUFF SHAMPOO 3.4OZ

    ALEVAI - ANTI DANDRUFF SHAMPOO 3.4OZ

  • ALEVAI - ANTI DANDRUFF SHAMPOO 8OZ

    ALEVAI - ANTI DANDRUFF SHAMPOO 8OZ

  • ALEVAI - ANTI DANDRUFF SHAMPOO 16OZ

    ALEVAI - ANTI DANDRUFF SHAMPOO 16OZ

  • ALEVAI - ANTI DANDRUFF SHAMPOO 32OZ

    ALEVAI - ANTI DANDRUFF SHAMPOO 32OZ

  • INGREDIENTS AND APPEARANCE
    ALEVAI - STEM CELL ANTI DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81457-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    BIOTIN (UNII: 6SO6U10H04)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81457-020-08226 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2021
    2NDC:81457-020-16453 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2021
    3NDC:81457-020-0496 g in 1 BOTTLE; Type 0: Not a Combination Product06/17/2022
    4NDC:81457-020-32906 g in 1 BOTTLE; Type 0: Not a Combination Product06/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/12/2021
    Labeler - ALEVAI PRODUCTS LLC (117842557)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(81457-020)
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