Label: DANDRENE- pyrithione zinc shampoo

  • 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 30, 2020

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  • ​Active ingredient

    Pyrithione zinc 2% w/w

  • ​Purpose

    Anti-dandruff

  • ​Uses

    Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling 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

    ​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

    ​Keep out of reach of children.  ​If swallowed, get medical help or contact Poison Control Center right away.

  • ​Directions

    Apply shampoo to wet hair and scalp with a gentle massage, leave in for 2-3 minutes, rinse.

    For best results use at least 2 times per week or as directed by a doctor.

    For maximum benefit use 4-5 times a week along with Dandrene Anti-Dandruff Conditioner.

  • ​Inactive ingredients

    Water, Sodium Lauryl Sulfoacetate, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Glyceryl Stearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Pomegranage Peel (Punica Granutum) Extract, Rosemary (Rosmarinus Officinalis) Leaf Extract, Shikimic Acid, Tioxolone, Emu Oil, Fragrance, Blue 1

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DANDRENE 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72249-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L)  
    LUPINUS ALBUS SEED (UNII: 24GB753W3B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
    SHIKIMIC ACID (UNII: 29MS2WI2NU)  
    TIOXOLONE (UNII: S0FAJ1R9CD)  
    EMU OIL (UNII: 344821WD61)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72249-100-011 in 1 BOX10/01/2018
    1205 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/01/2018
    Labeler - DIVINE SKIN LABORATORIES S.A. de C.V. (812464196)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.086365223manufacture(72249-100) , label(72249-100) , pack(72249-100)
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