Label: DENOREX EXTRA STRENGTH- salicylic acid shampoo

  • NDC Code(s): 62673-058-10
  • Packager: Neoteric Cosmetics, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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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

  • PRINCIPAL DISPLAY PANEL

    Den0059.jpgEXTRA STRENGTH DENOREX

    3 % Salicylic Acid

    DANDRUFF Control

    SHAMPOO +

    CONDITIONER

    10 FL OZ (296 mL)

    EXTRA STRENGTH DENOREX 3 % Salicylic Acid DANDRUFF Control SHAMPOO + CONDITIONER 10 FL OZ (296 mL)

  • INGREDIENTS AND APPEARANCE
    DENOREX EXTRA STRENGTH 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62673-058
    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:62673-058-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03211/01/2009
    Labeler - Neoteric Cosmetics, Inc. (790615181)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(62673-058) , manufacture(62673-058) , pack(62673-058) , label(62673-058)
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