Label: NIOXIN SCALP RECOVERY SOOTHING SERUM- pyrithione zinc lotion

  • NDC Code(s): 82157-005-10
  • Packager: Wella Operations US LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 0.1%

  • PURPOSE

    Purpose

    Anti-dandruff

  • INDICATIONS & USAGE

    Uses

    • helps prevent recurrence of 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

    • Apply after usage of Medicating Cleanser and Moisturizing Conditioner to scalp.
    • Apply to affected areas one to four times daily or as directed by a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients water, cetyl alcohol, stearamidopropyl dimethylamine, stearyl alcohol, distearyldimonium chloride, hydroxyethylcellulose, benzyl alcohol, phenoxyethanol, PEG-2M, dimethicone, fragrance, cetearyl alcohol, methylparaben, glyceryl stearate, oleyl alcohol, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, polysorbate 60, propylene glycol, camellia sinensis leaf extract, linalool, hexyl cinnamal, limonene, silica, geraniol, benzyl salicylate, alpha-isomethyl ionone, sodium polynaphthalenesulfonate, yeast extract, disodium phosphate, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, DMDM hydantoin, maltodextrin, cellulose gum, sodium phosphate, BHT, glucose, propylparaben, lactic acid, sodium benzoate, betula alba leaf extract, achillea millefolium extract, utica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, caramel, tartaric acid

  • QUESTIONS

    Questions? 1-800-935-5273

  • SPL UNCLASSIFIED SECTION

    NIOXIN SCALP RECOVERY® SOOTHING SERUM

    WITH PYRITHIONE ZINC IS A LEAVE-ON TREATMENT THAT HELPS RELIEVE DANDRUFF.

    Made in U.S.A. of U.S. and/or imported ingredients

    Dist Wella Operations US LLC. Calabasas, CA 91302

    www.nioxin.com

    1-800-935-5273

  • PRINCIPAL DISPLAY PANEL

    NIOXIN®

    PYRITHIONE ZINC

    SOOTHING SERUM

    STEP 3
    SCALP RECOVERY

    FOR ITCHY FLAKY SCALP

    COMBATS DANDRUFF FROM THE 1ST USE

    100 mL (3.38 FL OZ)

    82157-005 PDP

    82157-005 Back

  • INGREDIENTS AND APPEARANCE
    NIOXIN SCALP RECOVERY SOOTHING SERUM 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82157-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    ROSEMARY (UNII: IJ67X351P9)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    INOSITOL (UNII: 4L6452S749)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    BIOTIN (UNII: 6SO6U10H04)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    TARTARIC ACID (UNII: W4888I119H)  
    SAGE (UNII: 065C5D077J)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CARAMEL (UNII: T9D99G2B1R)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82157-005-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03212/01/2022
    Labeler - Wella Operations US LLC (117781338)
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