Label: MIZANI SCALP CARE ANTIDANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 49967-388-01, 49967-388-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Antidandruff

  • Use

    helps eliminate recurrence of scalp flaking, scaling, and itching associated with dandruff

  • Warnings

    For external use only

  • When using this product

    do not getinto eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and consult a physician if

    condition worsents or does not improve after regular use

  • Keep 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 physician
    • shake well
    • wet hair and apply 1 - 2 ounces throughout entire head
    • massage vigorously
    • leave on scalp 1 to 3 minutes
    • rinse well
    • repeat if necessary

  • Inactive ingredients

    water, sodium laureth sulfate, sodium lauryl sulfate, coco-betaine, glycol distearate, dimethicone, sodium chloride, glycerin, disodium cocoamphodiacetate, fragrance, sodium benzoate, sodium hydroxide, citric acid, polyquaternium-10, methylparaben, cocamide MIPA, carbomer, salicylic acid, menthol, ethylparaben, benzyl benzoate, propylene glycol, benzyl alcohol, sodium polynaphthalenesulfonate, benzyl salicylate, citronellol, geraniol, mentha piperita (peppermint) oil, alpha-isomethyl ionone, cellulose gum, cucumis sativus (cucumber) fruit extract, methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MIZANI SCALP CARE ANTIDANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-388
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    MENTHOL (UNII: L7T10EIP3A)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CUCUMBER (UNII: YY7C30VXJT)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-388-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2008
    2NDC:49967-388-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/01/2008
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.960317444manufacture(49967-388)
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