Label: ZINC PYRITHIONE shampoo

  • NDC Code(s): 70533-003-02, 70533-003-14
  • Packager: Harry's Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    for relief and to help prevent recurrence of
    flaking and itching associated with dandruff.

  • 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.

  • Directions

    • for best results use at least twice a week or as
    directed by a doctor.
    • shake before use.
    • wet hair, massage onto scalp, rinse, repeat if desired.

  • Inactive ingredients

    Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauric Acid, Disodium Cocoamphodiacetate, Decyl Glucoside, Polysorbate 20, Sodium Chloride, Citric Acid, Acrylates Copolymer, Glycerin, Phenoxyethanol, Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Menthol, Butylene Glycol, Lavandula Hybrida Oil, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Raphanus Sativus (Radish)
    Root Extract, Potassium Hydroxide , Sodium Lauroyl Lactylate, Lavandula Angustifolia (Lavender) Oil, Sodium Caproyl Lactylate,
    Propylene Glycol, Ferula Galbaniflua (Galbanum) Resin Oil, Sodium Polynaphthalenesulfonate, Sodium Acetate, Piper Nigrum (Pepper) Fruit Extract, Xanthan Gum, Isopropyl Alcohol, Benzoic Acid, Dehydroacetic Acid, Inga Alba Bark Extract, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.

  • QUESTIONS

    Questions? 1-888-212-6855

  • PRINCIPAL DISPLAY PANEL

    414ml NDC: 70533-003-14

    414 ml

    59ml NDC: 70533-003-02

    front NDC 70533-003-02back NDC 70533-003-02

  • INGREDIENTS AND APPEARANCE
    ZINC PYRITHIONE 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70533-003
    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
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)  
    ALOE (UNII: V5VD430YW9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PAPAYA (UNII: KU94FIY6JB)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    INGA ALBA BARK (UNII: 942K688993)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    RACEMENTHOL (UNII: YS08XHA860)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GALBANUM OIL (UNII: 211UF7M8N1)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0)  
    WHITE PEPPER (UNII: M29DW54Q9E)  
    RAPHANUS SATIVUS VAR. CAUDATUS ROOT (UNII: 1D6EC6L1NP)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    COCONUT ACID (UNII: 40U37V505D)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SODIUM CAPROYL LACTYLATE (UNII: 87WR3BHC09)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70533-003-14414 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    2NDC:70533-003-0259 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/01/2020
    Labeler - Harry's Inc. (079239206)
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