Label: RUGBY ANTI-DANDRUFF- selenium sulfide 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 January 12, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium Sulfide 1%

  • Purpose

    Anti-seborrheic dermatitis, anti-dandruff

  • Uses

    for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence.

  • Warnings

    For external use only

    As a doctor before use if

    condition covers a large area of the body.

    When using this product

    avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    for color-treated or permed hair, rinse thoroughly.

    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 a Poison Control Center right away.

  • Directions

    shake well
    shampoo, then rinse thoroughly
    for best results, use at least twice a week or as directed by a doctor.
  • Other information

    store at room temperature

  • Inactive ingredients

    water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33

  • Questions or comments?

    1-866-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories
    17177 N Laurel Park Dr., Suite 233
    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

    COMPARE TO
    ACTIVE INGREDIENT IN
    SELSUN BLUE®*

    Rugby®

    NDC 0536-1995-53

    New
    Formula

    ANTI •
    DANDRUFF
    SHAMPOO

    Selenium Sulfide 1%

    BLUE FORMULA
    FOR NORMAL HAIR

    Helps to control dandruff symptoms
    Leaves hair soft and manageable

    7 fl oz
    (207 mL)

    05-2675A

    PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    RUGBY ANTI-DANDRUFF 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q) Selenium Sulfide10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ammonium Laureth-2 Sulfate (UNII: 698O4Z48G6)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Coco Diethanolamide (UNII: 92005F972D)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Menthol, unspecified form (UNII: L7T10EIP3A)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1995-53207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H05/01/2012
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, Inc.255106239MANUFACTURE(0536-1995)