Label: ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER- pyrithione zinc lotion

  • NDC Code(s): 81457-002-04, 81457-002-08, 81457-002-16, 81457-002-32
  • Packager: ALEVAI PRODUCTS LLC
  • Category: HUMAN OTC DRUG LABEL

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

    For the relief of the symptoms of dandruff and seborrheic dermatitis

  • INDICATIONS & USAGE

    Do not get into eyes. If contact occurs rinse eyes thoroughly with water.

  • WARNINGS

    For external use only.

  • WHEN USING

    Do not get into eyes. If contact occurs rinse eyes thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    For best results use at least twice a week or as directed by the doctor.

    Apply a small amount quantity of the product into hair and massage the scalp.

    Allow the product to act for 5 minutes.

    Rinse thoroughly with water.

  • ASK DOCTOR

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

  • INACTIVE INGREDIENT

    Aqua, Cetearyl Alcohol, Behentrimonium Methosulfate, Stearyl Alcohol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Chlorophenesin, Caprylyl Glycol, Parfum, Organic Butyrospermum Parkii (Shea) Butter, Panthenol, Hydrolyzed Keratin, Hydroxypropyl Guar, Ricinus Communis (Castor) Seed Oil, Disodium EDTA, Propylene Glycol, Biotin, Argania Spinosa Kernel Oil, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Sodium Benzoate, Glycerin, Algae Extract, Citric Acid, Phenoxyethanol, Cetrimonium Chloride, Hexyl Cinnamal, Citral.

  • ALEVAI - ANTI DANDRUFF CONDITIONER 3.4OZ

    ALEVAI - ANTI DANDRUFF CONDITIONER 3.4OZ

  • ALEVAI - ANTI DANDRUFF CONDITIONER 8OZ

    ALEVAI - ANTI DANDRUFF CONDITIONER 8OZ

  • ALEVAI - ANTI DANDRUFF CONDITIONER 16OZ

    ALEVAI - ANTI DANDRUFF CONDITIONER 16OZ

  • ALEVAI - ANTI DANDRUFF CONDITIONER 32OZ

    ALEVAI - ANTI DANDRUFF CONDITIONER 32OZ

  • INGREDIENTS AND APPEARANCE
    ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81457-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    BIOTIN (UNII: 6SO6U10H04)  
    ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)  
    MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81457-002-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2021
    2NDC:81457-002-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2021
    3NDC:81457-002-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2022
    4NDC:81457-002-32946 mL 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 finalM03211/16/2021
    Labeler - ALEVAI PRODUCTS LLC (117842557)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(81457-002)
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