Label: NIOXIN SCALP RECOVERY SOOTHING SERUM- pyrithione zinc lotion/shampoo

  • NDC Code(s): 69282-006-10, 69282-006-50
  • Packager: The Wella Corporation
  • 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 21, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione Zinc 0.1%

  • Purpose

    Anti-dandruff, Anti-seborrheic dermatitis

  • Uses

    • helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.
  • Warnings

    For external use only.

    Ask a doctor before use if you have a condition that covers a large area of the body.

    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 this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply to affected areas one to four times daily or as directed by a doctor.
  • Inactive ingredients

    water, stearamidopropyl dimethylamine, cetyl alcohol, hydroxyethylcellulose, quaternium-18, benzyl alcohol, phenoxyethanol, stearyl alcohol, PEG-2M, dimethicone, cetearyl alcohol, methylparaben, propylparaben, fragrance, glyceryl stearate, oleyl alcohol, citric acid, polysorbate 60, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, yeast extract, camellia sinensis leaf extract, lecithin, PPG-26-buteth-26, saccharomyces/magnesium ferment, dimethyl isosorbide, carnitine HCL, PEG/PPG-18/18 dimethicone, ethoxydiglycol, oryza sativa (rice) bran, PEG-40 hydrogenated castor oil, biotin/folic acid/cyanocobalamin/niacinamide/pantothenic acid/pyridoxine/riboflavin/thiamine/yeast polypeptides, saccharomyces/iron ferment, saccharomyces/copper ferment, saccharomyces/silicon ferment, saccharomyces/zinc ferment, acacia senegal gum, ubiquinone.

  • Questions?

    1-800-935-5273

  • SPL UNCLASSIFIED SECTION

    Dist. by
    THE WELLA CORPORATION,
    WOODLAND HILLS, CA 91367

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    NIOXIN ®
    SCALP RECOVERY ®

    For a dry, itchy scalp

    PYRITHIONE ZINC
    DANDRUFF AND
    SEBORRHEIC
    DERMATITIS
    TREATMENT

    SOOTHING
    SERUM

    100% FLAKE FREE
    ELIMINATION OF
    VISIBLE FLAKES WITH
    REGULAR USE*

    100 mL (3.38 FL OZ)

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NIOXIN SCALP RECOVERY  SOOTHING SERUM
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69282-006
    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
    WATER (UNII: 059QF0KO0R)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    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)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    RICE BRAN (UNII: R60QEP13IC)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ACACIA (UNII: 5C5403N26O)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69282-006-501 in 1 CARTON07/01/2016
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69282-006-101 in 1 CARTON07/01/2016
    2100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/01/2016
    Labeler - The Wella Corporation (001399815)
    Registrant - Coty US LLC (039056361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.118542196manufacture(69282-006)
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