Label: RUGBY ANTI-DANDRUFF- selenium sulfide shampoo 

  • NDC Code(s): 0536-1995-53
  • Packager: Rugby Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Selenium sulfide 1%

    Close
  • Purpose

    Anti-dandruff

    Close
  • Use

    relieves scalp flaking and itching due to dandruff and seborrheic dermatitis, and helps prevent their recurrence

    Close
  • Warnings

    For external use only

    Ask a doctor before use if you have seborrheic dermatitis in areas other than the scalp

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • for color-treated or permed hair, it is especially important to rinse thoroughly.

    Stop use and ask a doctor if condition worsens or does not improve after regular use

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

    Close
  • Directions

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

    store at room temperature

    Close
  • Inactive ingredients

    water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamidopropyl betaine, cocamide DEA, magnesium aluminum silicate, hypromellose, fragrance, menthol, DMDM hydantoin, citric acid, sodium chloride, FD&C blue no. 1, D&C red no. 33

    Close
  • Questions or comments?

    Call 1-800-645-2158 9 am - 5 pm ET,
    Monday - Friday

    Close
  • 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

    05-2675

    7 fl oz
    (207 mL)

    SATISFACTION GUARANTEED
    Rugby
    • OR YOUR MONEY BACK •

    Principal Display Panel - 207 mL Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    RUGBY ANTI-DANDRUFF 
    selenium sulfide shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-1995
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Selenium Sulfide (Selenium Sulfide) Selenium Sulfide 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Ammonium Laureth-2 Sulfate  
    Ammonium Lauryl Sulfate  
    Cocamidopropyl Betaine  
    Coco Diethanolamide  
    Magnesium Aluminum Silicate  
    Hypromelloses  
    Menthol  
    DMDM Hydantoin  
    Citric Acid Monohydrate  
    Sodium Chloride  
    Fd&C Blue No. 1  
    D&C Red No. 33  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1995-53 207 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part358H 05/01/2012
    Labeler - Rugby Laboratories, Inc. (191427277)
    Registrant - Garcoa, Inc. (103039178)
    Establishment
    Name Address ID/FEI Business Operations
    Garcoa, Inc. 103039178 MANUFACTURE(0536-1995)
    Close