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

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

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredients

    Pyrithione Zinc 2%

    Purpose

    Anti-dandruff

  • Uses:

    • Helps eliminate reoccurrence of sclap itching, irritation, redness, and falking associated with dandruff. 
  • 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.

  • Directions:

    • For best results use at least twice a week or as directed by a doctor.
    • Apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.
  • Other information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    Aqua (Deionized Water), PEG-80 Sorbitan Laurate, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Disodium Cocamidopropyl Betaine, Sodium Chloride, PEG-150 Distearate, Laureth-13 Carboxylate, Lauramine Oxide, Butylene Glycol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Apigenin, Oleanolic Acid, Biotonyl Tripeptide-1, Argania Spinosa (Argan) oil, Serenoa Serrulata (Saw Palmetto) Extract, dl-Panthenol, Niacin, Biotin, Hydrolyzed Keratin Protein, L-Proline, Tocopheryl Acetate, Lamanaria Digitata (Sea Kelp) Extract, Spirulina Platensis (Spirulina) Extract, , Camellia Sinesis (Green Tea) Extract, Cocous Nucifera (Coconut) Oil, Malus Domestica (Apple) Fruit Cell Culture Extract, L-Leucine, L-Valine, Buddleja Davidii Meristem Cell Culture, Xanthan Gum, Crithmum Maritimum (Sea Fennel) Extract, Leontopodium Alpinum (Edelweiss) Stem Extarct, L-Threonine, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    ALEVAI STEM CELL ANTI-DANDRUFF 
    pyrithione zinc solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81457-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    APIGENIN (UNII: 7V515PI7F6)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACIN (UNII: 2679MF687A)  
    BIOTIN (UNII: 6SO6U10H04)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    APPLE (UNII: B423VGH5S9)  
    LEUCINE (UNII: GMW67QNF9C)  
    VALINE (UNII: HG18B9YRS7)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)  
    LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)  
    THREONINE (UNII: 2ZD004190S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81457-124-00236 mL in 1 CYLINDER; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03202/01/2021
    Labeler - Alevai Products LLC (117842557)
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