Label: DIVINE DANDRENE 2%- zinc pyrithione shampoo

  • NDC Code(s): 69188-200-07
  • Packager: DS Healthcare Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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  • Active ingredient

    Zinc Pyrithione 2%

  • 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 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

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

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

    For best results use atleast 2 times per week or as direacted by a doctor

    For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff conditioner

  • Inactive ingredients

    Water, Disodium Laureth Sulfosuccinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Sodium Lauroyl Sarcosinate, Sodium Lauryl Suloacetate, Glycol Distearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine
    Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Punica Granatum Extract, Rosmarinus Officinalis Leaf Extract, Shikimic Acid, Tioxolone, Blue 1

  • Product label

    image descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    DIVINE DANDRENE 2% 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69188-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L)  
    SURINAMINE (UNII: AIQ58N56TM)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)  
    ROSEMARY (UNII: IJ67X351P9)  
    SHIKIMIC ACID (UNII: 29MS2WI2NU)  
    TIOXOLONE (UNII: S0FAJ1R9CD)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69188-200-07205 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/01/2021
    Labeler - DS Healthcare Group, Inc. (015504134)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc086365223manufacture(69188-200)
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