Label: NIOXIN SCALP RECOVERY MOISTURIZING CONDITIONER- pyrithione zinc lotion

  • NDC Code(s): 82157-004-20
  • Packager: Wella Operations US 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 December 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 0.5%

  • 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

    • For best results use at least twice a week or as directed by a doctor.
    • Use daily for maximum dandruff control.
    • Apply to wet scalp and hair, leave for 1-3 minutes. Rinse well.
  • INACTIVE INGREDIENT

    Inactive ingredients water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, dimethicone, glutamic acid, benzyl alcohol, phenoxyethanol, fragrance, methylparaben, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, propylene glycol, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, sodium polynaphthalenesulfonate, geraniol, DMDM hydantoin, cellulose gum, yeast extract, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, maltodextrin, glucose, propylparaben, lactic acid, sodium benzoate, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, achillea millefolium extract, betula alba leaf extract, potassium sorbate, inositol, calcium pantothenate, tartaric acid, caramel.

  • QUESTIONS

    Questions?

    1-800-935-5273

  • SPL UNCLASSIFIED SECTION

    NIOXIN SCALP RECOVERY® MOISTURIZING CONDITIONER

    WITH PYRITHIONE ZINC THAT HELPS REDUCE DANDRUFF AND PROVIDE SMOOTHNESS. AS PART OF A COMPLETE SCALP AND HAIR CARE SYSTEM, THIS MOISTURIZING CONDITIONER LEAVES HAIR NOURISHED AND MOISTURIZED.

    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 MOISTURIZING CONDITIONER

    STEP 2

    SCALP RECOVERY ®

    FOR ITCHY, FLAKY SCALP

    COMPATES DANDRUFF FROM THE 1ST USE

    200 mL (6.76 FL OZ)

    82157-004 PDP

    82157-004 Back rev

  • INGREDIENTS AND APPEARANCE
    NIOXIN SCALP RECOVERY MOISTURIZING CONDITIONER 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82157-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
    INOSITOL (UNII: 4L6452S749)  
    TARTARIC ACID (UNII: W4888I119H)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    ROSEMARY (UNII: IJ67X351P9)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GERANIOL (UNII: L837108USY)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BIOTIN (UNII: 6SO6U10H04)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    SAGE (UNII: 065C5D077J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82157-004-20200 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 finalM03212/01/2022
    Labeler - Wella Operations US LLC (117781338)
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