Label: SELENIUM SULFIDE shampoo

  • Category: HUMAN OTC DRUG LABEL

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 31, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Selenium sulfide 1%

  • Purpose

    Antidandruff

  • Use

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

  • 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, 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.
  • Inactive Ingredients

    water, ammonium lauryl sulfate, ammonium laureth sulfate, dihydrogenated tallow phthalic acid amide, sodium chloride, cocamide DEA, dimethicone, aloe barbadensis leaf juice, titanium dioxide, hydroxypropyl methylcellulose, sodium isostearyl lactylate, DMDM hydantoin, fragrance, citric acid, sodium citrate, FD&C blue no.1 (245-067)

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    Sonar Products, Inc.
    609 Industrial Road
    Carlstadt, NJ 07072

  • PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

    NDC 65255-409-88

    SONAR PRODUCTS, INC.

    SELENIUM
    SULFIDE
    1% SHAMPOO

    Moisturizing Dandruff
    Shampoo

    11 Fl. Oz. (325 mL)

    Principal Display Panel - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SELENIUM SULFIDE 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65255-409
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorTURQUOISEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65255-409-03325 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H02/08/2012
    Labeler - Sonar Products, Inc (104283945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sonar Products, Inc104283945MANUFACTURE(65255-409) , LABEL(65255-409)
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