Label: ZINC PYRITHIONE shampoo

  • NDC Code(s): 70533-004-02, 70533-004-14
  • Packager: Harry's Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • Active Ingredients

    Zinc Pyrithione 2%

  • Purpose

    Anti-dandruff,

    Ant-seborrheic dermatitis

  • Uses

    for relief and to help prevent recurrence of flaking and itching 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 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, Acrylates Copolymer, Citric Acid, Glycerin, Phenoxyethanol, Polyquaternium-39, Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Propanediol, Menthol, Raphanus Sativus (Radish) Root Extract, Lavandula Hybrida Oil, Propylene Glycol, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Potassium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Ziziphus Joazeiro Bark Extract, Sodium Polynaphthalenesulfonate, Ferula Galbaniflua (Galbanum) Resin Oil, Xanthan Gum, Sodium Acetate, Butylene Glycol, Sodium Benzoate, Isopropyl Alcohol, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.

  • QUESTIONS

    Questions? 1-888-212-6855

  • PRINCIPAL DISPLAY PANEL

    414 mL NDC: 70533-004-14 Antidandruff L3 414mL

    60 mL NDC: 70533-004-02 Antidandruff L3 60mL FrontAntidandruff L3 60mL Back

  • INGREDIENTS AND APPEARANCE
    ZINC PYRITHIONE 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70533-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PAPAYA (UNII: KU94FIY6JB)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GALBANUM OIL (UNII: 211UF7M8N1)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WHITE PEPPER (UNII: M29DW54Q9E)  
    COCONUT ACID (UNII: 40U37V505D)  
    SODIUM CAPROYL LACTYLATE (UNII: 87WR3BHC09)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX)  
    SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)  
    ALOE (UNII: V5VD430YW9)  
    INGA ALBA BARK (UNII: 942K688993)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    RACEMENTHOL (UNII: YS08XHA860)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    RAPHANUS SATIVUS VAR. CAUDATUS ROOT (UNII: 1D6EC6L1NP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70533-004-14414 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    2NDC:70533-004-0259 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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