Label: ALEVAI - ANTI DANDRUFF SCALP SERUM- zinc pyrithione cream

  • NDC Code(s): 81457-012-01, 81457-012-02
  • 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 March 7, 2023

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  • ACTIVE INGREDIENT

    Zinc Pyrithione 0.12%

  • PURPOSE

    Anti-dandruff

  • USES:

    For the relief of flaking and itching associated with dandruff.

  • WARNINGS

    ​For external use only.

  • WHEN USING

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

  • STOP USE AND ASK 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:

    Shake well. Apply and massage directly into affected areas. Can be used in dry or damp hair. Do not Rinse off. For best results, use 1 to 4 times daily or as directed by a doctor.

  • INACTIVE INGREDIENT

    Aqua, Polysorbate 20, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glycerin, Urtica Dioica (Nettle) Extract, Betula Alba Bark Extract, Juglans Regia (Walnut) Leaf Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Phenoxyethanol, Sodium Lactate, Sodium Gluconate, Benzyl Alcohol, Benzoic Acid, Sorbic Acid, Xanthan Gum, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Allium Sativum Bulb Extract, Rosmarinus Officinalis (Rosemary) Oil, Sodium Hydroxide, Linalool, Limonene.

  • ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 1 FL OZ

    ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 30

  • ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 2 FL OZ

    ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 60

  • INGREDIENTS AND APPEARANCE
    ALEVAI - ANTI DANDRUFF SCALP SERUM 
    zinc pyrithione cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81457-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBIC ACID (UNII: X045WJ989B)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    ALLIUM SATIVUM WHOLE (UNII: IIF21WT8O3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JUGLANS REGIA LEAF (UNII: 85HKB87105)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81457-012-011 in 1 BOX04/17/2023
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:81457-012-021 in 1 BOX04/17/2023
    260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03204/17/2023
    Labeler - ALEVAI PRODUCTS LLC (117842557)
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