Label: DERMASOLVE MEDICATED- salicylic acid lotion/shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2024

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  • ACTIVE INGREDIENT

    Salicylic Acid 3%

  • PURPOSE

    Psoriasis/Seborrheic Dermatitis/Dandruff

  • INDICATIONS & USAGE

    Controls the symptoms associated with Psoriasis, Seborrheic Dermatitis and/or Dandruff including itching, scaling, flaking, redness, and irritation.

  • WARNINGS

    For external use only.

    Ask a doctor before use if you have a condition that covers a large are 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.

  • DOSAGE & ADMINISTRATION

    Wet hair thoroughly. Apply shampoo and massage into scalp. Allow lather to remon on scalp for several minutes. Rinse hair well and repeat. For best results use at least twice a week or as directed by a doctor. A patch test should be done prior to use if you are concerned about any ingredients. This is a low foam shampoo.

  • INACTIVE INGREDIENT

    Deionized Water, Sodium Laryl Ether Sulfate, Coamidopropyl Betaine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Ethylene Glycol Monostearate, Egg Powder, Aloe Barbadensis Leaf Juice, Polyquaternium-7, Mentha Piperita Oil (Peppermint Oil), Propylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Triethanolamine, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DERMASOLVE MEDICATED 
    salicylic acid lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84285-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETEARETH-20 (UNII: YRC528SWUY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIETHYLENE GLYCOL MONOSTEARATE (UNII: TWG3GKC3M9)  
    ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-7 (UNII: 0L414VCS5Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EGG (UNII: 291P45F896)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84285-101-08226 g in 1 BOTTLE; Type 0: Not a Combination Product10/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/21/2024
    Labeler - Fortitude Health, LLC (064309530)
    Registrant - Stream2Sea LLC (052920828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stream2Sea, LLC052920828manufacture(84285-101)
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