Label: DANDRUFF DETOX- pyrithione zinc shampoo

  • 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 January 2, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione Zinc 1%

  • PURPOSE

    Purpose

    Anti-dandruff

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    For external use only.

    When using this product avoid contact with 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hair, massage shampoo into scalp.
    • rinse off and repeat if desired.
    • for best results, use at least twice a week or as directed by a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water/Aqua/Eau, Sodium C14-16 Olefin Sulfonate, Cocamide MIPA, Cocamidopropyl Betaine, Propanediol, Polyacrylate-1 Crosspolymer, Fragrance/Parfum, Salicylic Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Saccharide Isomerate, Raphanus Sativus (Radish) Root Extract, Propylene Glycol, Citric Acid, Sodium Polynaphthalenesulfonate, Sodium Chloride, Xanthan Gum, Persea Gratissima (Avocado) Oil, Argania Spinosa Oil, Glycine Soja (Soybean) Seed Extract, Salvia Hispanica Seed Oil, Ceramide NG, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract

  • QUESTIONS

    Questions or comments?

    Phone 1-800-368-0038 for reporting serious adverse events associated with use of this product, or visit us at forhims.com.

  • PRINCIPAL DISPLAY PANEL

    hims

    anti-dandruff shampoo

    dandruff detox

    formulated with 1% pyrithione zinc to treat dandruff at the source and salicylic acid to remove buildup

    ANTI-DANDRUFF

    evergreen mint scent

    190 mL / 6.4 FL OZ

    hims ®

    Distributed by Hims, Inc.

    2269 Chestnut Street #523

    San Francisco, CA 94123

    Made in the USA with US and imported materials

    label

  • INGREDIENTS AND APPEARANCE
    DANDRUFF DETOX 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71730-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    ROSEMARY (UNII: IJ67X351P9)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    RADISH (UNII: EM5RP35463)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)  
    POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71730-101-04190 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03202/14/2023
    Labeler - HIMS INC (080678637)
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