Label: NATURALTECH PURIFYING ANTI-DANDRUFF- selenium sulfide shampoo

  • NDC Code(s): 64724-1016-1, 64724-1016-2, 64724-1016-3
  • Packager: Davines S.p.A.
  • 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.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium Sulfide, micronized 0,6 %

  • 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

    • wet hair
    • apply shampoo and work into a lather
    • 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, Cocamidopropyl Betaine, Propylene Glycol, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Lauroyl Methyl Isethionate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Oleate, Taraxacum Officinale (Dandelion) Root Extract, Coco-Glucoside, Polysorbate 20, Sodium Benzoate, Citric Acid, Sodium Chloride, Trisodium Ethylenediamine Disuccinate, Potassium Sorbate, 2-Bromo-2-Nitropropane-1,3-Diol, Fragrance.

  • PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

    NATURALTECH™

    PURIFYING ANTI-DANDRUFF SHAMPOO

    SHAMPOO FOR SCALP WITH OILY OR DRY DANDRUFF

    WITH DANDELION PHYTOCEUTICALS

    1000 mL 33.81 Fl. Oz.

    davinesshampoo

  • INGREDIENTS AND APPEARANCE
    NATURALTECH PURIFYING ANTI-DANDRUFF 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64724-1016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    TARAXACUM OFFICINALE (UNII: 39981FM375)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64724-1016-112 mL in 1 BOTTLE; Type 0: Not a Combination Product02/29/201211/28/2022
    2NDC:64724-1016-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/29/2012
    3NDC:64724-1016-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/29/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03202/29/2012
    Labeler - Davines S.p.A. (430193664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biokosmes SRL 436948830manufacture(64724-1016)