Label: NIOXIN SCALP RECOVERY MEDICATING CLEANSER- pyrithione zinc lotion/shampoo

  • NDC Code(s): 69282-005-10, 69282-005-20, 69282-005-50
  • 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 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

    • 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 ingredients

    WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, FRAGRANCE, DMDM HYDANTOIN, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, MENTHA ARVENSIS LEAF OIL, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, YEAST EXTRACT, LECITHIN, SACCHAROMYCES/MAGNESIUM FERMENT, BIOTIN/FOLIC ACID/CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST POLYPEPTIDES, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT.

  • Questions?

    1-800-935-5273

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

    NIOXIN ®
    SCALP RECOVERY ®

    For a dry, itchy scalp

    PYRITHIONE ZINC
    DANDRUFF AND
    SEBORRHEIC
    DERMATITIS
    SHAMPOO

    MEDICATING
    CLEANSER

    100% FLAKE FREE
    ELIMINATION OF
    VISIBLE FLAKES WITH
    REGULAR USE

    99405984

    200 mL (6.76 FL OZ)

    PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    NIOXIN SCALP RECOVERY  MEDICATING CLEANSER
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69282-005
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69282-005-501 in 1 CARTON07/01/2016
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69282-005-20200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2016
    3NDC:69282-005-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2016
    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(69282-005)
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