Label: LEUDINE ANTI-DANDRUFF- 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 February 13, 2013

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  • Active ingredient

    Pyrithione Zinc 1%

  • Purpose

    Anti-dandruff

  • Keep Out of Reach of Children

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

  • Uses

    for relief of flaking and itching due to dandruff, and to help prevent their recurrence.

  • 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.
  • Directions

    • for maximum dandruff control, use every time you shampoo
    • wet hair, massage onto scalp, rinse, repeat if desired
    • for best results use at least twice a week or as directed by a doctor.
  • Inactive ingredients

    Acrylates Copolymer, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Ammonium Xylenesulfonate, Citric Acid, Cocamide MEA, Cocamidopropyl PG-Dimonium Chloride, Fragrance, Glycol Distearate, Guar Hydroxypropyltrimonium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Panthenol, Sodium Chloride, Triethanolamine, Water, Blue 1.

  • Questions?

    1-800-944-5846

  • Package/Label Principal Display Panel

    L'EUDINE

    anti-dandruff Shampoo

    2.0 fl. oz. (60 mL)

    MADE IN USA

    Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    LEUDINE ANTI-DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76482-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW) (UNII: XRK36F13ZZ)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76482-013-0260 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/01/2013
    Labeler - B&R Products Inc (085560514)
    Registrant - B&R Products Inc (085560514)
    Establishment
    NameAddressID/FEIBusiness Operations
    B&R Products Inc085560514MANUFACTURE(76482-013)
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