Label: DENOREX EXTRA STRENGTH- salicylic acid 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 June 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients:

    Salicylic acid 3%

  • Purpose

    Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

  • Uses

    • Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis
    • Helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis
  • Warnings

    For external use only.

    Ask a doctor before use if you have

    a condition that covers a large area of the body.

    When using this product

    avoid contact with the 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 right away.

  • Directions

    • Shake well
    • apply to wet hair
    • gently massage into hair and scalp to work up a lather
    • rinse thoroughly and repeat
    • for best results, use at least twice weekly or as directed by a doctor
  • Other information

    Store at 20º-25º C (68º – 77º F)

  • Inactive ingredients

    cocamidopropyl betaine, D&C Red No. 33, D&C Yellow No. 10, dimethicone PEG-8 meadowfoamate, FD&C Blue No. 1, FD&C Yellow No. 6, fragrance, glycol distearate, menthol, panthenol, polyquaternium-10, PPG-2 hydroxyethyl cocamide, propylene glycol, sodium C14-C16 olefin sulfonate, sodium citrate, vitamin E acetate, water

  • Questions?

    1-800-220-0151

    www.denorex.net

  • PRINCIPAL DISPLAY PANEL

    Den0059.jpg

    denorex-extra-strength-01.jpg

  • INGREDIENTS AND APPEARANCE
    DENOREX EXTRA STRENGTH 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0059
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MENTHOL (UNII: L7T10EIP3A)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0059-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/17/2019
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-0059) , analysis(0395-0059) , pack(0395-0059) , label(0395-0059)
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