Label: NIOXIN SCALP RECOVERY MEDICATING CLEANSER- pyrithione zinc shampoo

  • NDC Code(s): 82157-003-20
  • Packager: Wella Operations US LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 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

    • For best results use at least twice a week or as directed by a doctor.
    • Use daily for maximum dandruff control.
    • Massage on to wet scalp and hair. Rinse. Repeat if desired.
  • INACTIVE INGREDIENT

    Inactive ingredients water, sodium laureth sulfate, PEG-3 distearate, sodium laureth-8 sulfate, sodium chloride, cocamidopropyl betaine, acrylates/steareth-20 methacrylate copolymer, magnesium laureth-8 sulfate, magnesium laureth sulfate, sodium oleth sulfate, fragrance, sodium benzoate, citric acid, DMDM hydantoin, mentha arvensis leaf oil, mentha piperita (peppermint) oil, magnesium oleth sulfate, sodium hydroxide, polyquaternium-10, propylene glycol, benzoic acid, linalool, hexyl cinnamal, camellia sinensis leaf extract, sodium polynaphthalenesulfonate, benzyl alcohol, limonene, geraniol, cellulose gum, yeast extract, niacinamide, tocopheryl acetate, panthenol, biotin, lecithin, ethoxydiglycol, maltodextrin, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, urtica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.

  • QUESTIONS

    Questions?

    1-800-935-5273

  • SPL UNCLASSIFIED SECTION

    NIOXIN SCALP RECOVERY®

    MEDICATING CLEANSER

    IS AN ANTIDANDRUFF SHAMPOO WITH PYRITHIONE ZINC THAT HELPS PREVENT AND RELIEVE THE SYMPTOMS OF DANDRUFF, SUCH AS SCALP ITCHING AND FLAKING.

    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 MEDICATING CLEANSER

    STEP 1

    SCALP RECOVERY®
    FOR ITCHY, FLAKY SCALP

    COMBATS DANDRUFF FROM THE 1ST USE

    200 mL (6.76 FL OZ)

    82157-003 PDP

    82157-003 back rev

  • INGREDIENTS AND APPEARANCE
    NIOXIN SCALP RECOVERY MEDICATING CLEANSER 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82157-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM OLETH SULFATE (UNII: LCQ4WP3DTL)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    PEG-3 DISTEARATE (UNII: 8420ECX438)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
    FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    SODIUM OLEYL SULFATE (UNII: 46F21X4586)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA)  
    MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BIOTIN (UNII: 6SO6U10H04)  
    SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0)  
    GERANIOL (UNII: L837108USY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ROSEMARY (UNII: IJ67X351P9)  
    INOSITOL (UNII: 4L6452S749)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SAGE (UNII: 065C5D077J)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    TARTARIC ACID (UNII: W4888I119H)  
    CARAMEL (UNII: T9D99G2B1R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82157-003-20200 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 DrugM03212/01/2022
    Labeler - Wella Operations US LLC (117781338)