Label: SEBEX- salicylic acid and sulfur shampoo 

  • Label RSS
  • 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.

  • Active ingredient

    Colloidal sulfur, 2%
    Salicylic acid, 2%

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  • Purpose

     Antidandruff

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  • Use

    • Controls the symptoms of:

      -Dandruff
      -Seborrheic dermatitis
      -Psoriasis
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  • Warning

     For external use only

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  • For external use only

     For external use only

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  • Do not use

     Do not use for seborrheic dermatitis or psoriasis if condition covers a large area of the body

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  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product

    • avoid contact with eyes
    • if contact occurs, rise eyes thoroughly with water
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  • Stop use and ask a doctor if

    condition worsens or does not improve after regular use

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  • Pregnancy/breast-feeding warning
  • Keep out of reach of children

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

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  • 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
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  • Other information

    • store at room temperature
    • see container for Lot Number and Expiration Date
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  • Inactive ingredients

    Disodium cocoamphodipropionate, docusate sodium, fragrance, hydrochloric acid, isopropyl palmitate, octoxynol-1, PEG 85 lanolin, purified water, quaternium-15, sodium lauryl sulfate

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  • Questions?

    Questions or comments?
    Call 1-800-645-2158

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  • Principal Display Panel

    SEBEX
    Medicated Dandruff, Seborrheic Dermatitis &
    Psoriasis Shampoo

    Sebex

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  • INGREDIENTS AND APPEARANCE
    SEBEX 
    salicylic acid, colloidal sulfur shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-1962
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    salicylic acid (salicylic acid) salicylic acid 20 mg  in 1000 mL
    sulfur (sulfur) sulfur 20 mg  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    DISODIUM COCOAMPHODIPROPIONATE  
    DOCUSATE SODIUM  
    HYDROCHLORIC ACID  
    ISOPROPYL PALMITATE  
    OCTOXYNOL-1  
    PEG-8 STEARATE  
    LANOLIN  
    WATER  
    QUATERNIUM-15  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color BLUE (Aqua Blue) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1962-97 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 10/29/2012
    Labeler - Rugby Laboratories (191427277)
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