Label: SEBEX ANTIDANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- salicylic acid, sulfur 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 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Salicylic Acid, 2% }
    Sulfur, 2%    		Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
  • Uses

    controls the symptoms of:

    • dandruff
    • seborrheic dermatitis
    • psoriasis
  • Warnings

    For external use only

    Do not use

    • If condition covers a large area of the body, consult your doctor before using this product
    • this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor

    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 a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • SHAKE WELL BEFORE USE
    • wet the scalp or skin and massage in enough shampoo to work up a lather
    • massage for 3-5 minutes and rinse out thoroughly
    • repeat application and rinse thoroughly again
    • for best results, use at least twice a week or as directed by a doctor
  • Other information

    • store at room temperature
    • see container for Lot No. & Exp. date
  • Inactive ingredients

    water, sodium lauryl sulfate, disodium cocoamphodipropionate, acrylates copolymer, citric acid, PEG-75 lanolin, fragrance, quaternium-15, diethylhexyl sodium sulfosuccinate, isopropyl palmitate, sodium hydroxide.

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    RUGBY® LABORATORIES
    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    Rugby®

    NDC 0536-1962-97

    Sebex

    Medicated Dandruff,
    Seborrheic Dermatitis,
    and Psoriasis Shampoo

    4 FL OZ (118 mL)

    Principal Display Panel - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SEBEX   ANTIDANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS
    salicylic acid, sulfur shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1962
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid20 mg  in 1000 mL
    sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) sulfur20 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    PEG-75 Lanolin (UNII: 09179OX7TB)  
    Quaternium-15 (UNII: E40U03LEM0)  
    Docusate Sodium (UNII: F05Q2T2JA0)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1962-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/29/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H10/29/2012
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, Inc.255106239MANUFACTURE(0536-1962)
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