Label: NATURALTECH PURIFYING ANTI-DANDRUFF- pyrithione zinc gel

  • 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 November 28, 2022

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

View All Sections
  • Active Ingredient

    Zinc Pyrithione 0,48%

  • Purpose

    Antidandruff

  • Uses

    For relief of the symptoms of dandruff

  • Warnings

    For external use only

  • Stop use and ask a doctor if

    condition worsens or does not improve after regular use

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Spread carefully over the whole scalp, or only on areas affected by dandruff, massaging in gently.
    • Leave to process for 10 minutes.
    • Rinse thoroughly.
    • For best results use at least twice a week or as directed by a doctor.
  • Other information

    • you may report a serious adverse event from using this product to Report Reaction, LLC PO Box 22, Plainsboro, NJ
  • Inactive Ingredients

    Water, Polysorbate 20, Pentasodium Pentetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, Glycerin, Bisabolol, Piroctone Olamine, Taraxacum Officinale (Dandelion) Root Extract, Tocopherol, Tetrasodium EDTA, Sodium Hydroxide, Linalool, Fragrance.

  • PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton Label

    NATURALTECH™

    PURIFYING ANTI-DANDRUFF GEL

    TREATMENT FOR SCALP WITH

    OILY OR DRY DANDRUFF

    WITH DANDELION PHYTOCEUTICALS

    150 mL 5.07 Fl. Oz.

    davines

    gel

  • INGREDIENTS AND APPEARANCE
    NATURALTECH PURIFYING ANTI-DANDRUFF 
    pyrithione zinc gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64724-1017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.48 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    TARAXACUM OFFICINALE (UNII: 39981FM375)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64724-1017-11 in 1 CARTON02/29/2012
    1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03202/29/2012
    Labeler - Davines S.p.A. (430193664)
    Registrant - Davines S.p.A. (430193664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biokosmes SRL436948830manufacture(64724-1017)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!