Label: PANROSA FRESH CLEAN PYRITHIONE ZINC DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 50302-400-43
  • Packager: Panrosa Enterprises, Inc.
  • 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 April 6, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Antidandruff

  • Use

    helps 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 Poison Control Center right away.

  • Directions

    • Shake well
    • Wet hair
    • Massage shampoo into scalp
    • Rinse
    • Repeat if desired
    • For best results, use at least twice a week or as directed by a doctor
    • For maximum dandruff control, use every time you shampoo
  • Inactive ingredients

    Water, Sodium Larueth Sulfate, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamide MEA, Glycol Distearate, Dimethicone, Trideceth-5, Sodium Dodecylbenzenesulfonate, Sodium Chloride, Panthenol, Hydroxypropyl Guar, Cetearyl Alcohol, Fragrance, Allantoin, Disodium EDTA, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone.

  • Panrosa FRESH CLEAN Pyrithione Zinc Dandruff Shampoo 443.66ml (50320-400-43)

    PANROSA

    FRESH CLEAN

    BASIC HAIR CARE

    Pyrithione Zinc Dandruff Shampoo

    Deep cleaning for soothing relief of itchy, flaky scalp



    15 fl oz (443.6 mL)

    Distributed by:

    Panrosa

    ENTERPRISES, INC.

    1969 S. Campus Ave.

    Ontario, California 91761 U.S.A.

    Made in China

    Questions please visit our web site at www.panrosa.com


    Package is recyclable where facilities exist.



    label


  • INGREDIENTS AND APPEARANCE
    PANROSA FRESH CLEAN PYRITHIONE ZINC DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-400
    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)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIDECETH-5 (UNII: 76X6L6EU5K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-400-43443.6 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/01/2013
    Labeler - Panrosa Enterprises, Inc. (859957578)