Label: ZOLIDYNE- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Pyrithione, 2%

  • Purpose

    Antidandruff, Seborrheic Dermatitis

  • Uses

    • A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.
  • Warnings

    For external use only

    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
    • If condition worsens or does not improve after regular use of this product as directed, consult a doctor
    • If condition covers a large area of the body, consult your doctor before using this product

    • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
  • Directions

    Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes

    • For best results, use at least twice a week or as directed by your doctor.
  • Inactive ingredients

    Ammonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water.

  • PRINCIPAL DISPLAY PANEL - 200 ml Tube Label

    DERMA
    TOPIX

    zolidyne
    shampoo

    Zinc Pyrithione, 2%

    Net 6.7 fl. oz. (200 ml.)

    Topix Pharmaceuticals, Inc.
    N. Amityville, NY 11701

    PRINCIPAL DISPLAY PANEL - 200 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    ZOLIDYNE 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-203-67200 mL in 1 TUBE; Type 0: Not a Combination Product01/22/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03201/22/1993
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-203)
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