DUSEL PSORIASIS DEAD SEA SALT THERAPY (SALICYLIC ACID) CREAM [NANOVITA ONE LLC]

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DUSEL PSORIASIS DEAD SEA SALT THERAPY (SALICYLIC ACID) CREAM [NANOVITA ONE LLC]
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NDC 70656-740-01
Set ID 7be4b782-e4cd-4e7b-b61e-bc23080fe119
Category HUMAN OTC DRUG LABEL
Packager Nanovita One LLC
Generic Name
Product Class
Product Number
Application Number PART358H
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  • Drug Facts:

  • Active Ingredient:

    Salicylic Acid 2.00%

    Psoriasis treatment

  • Uses:

    For relief or controls the symptoms of psoriasis.

  • Warnings:

    For external use only

    Do not use

    •  if you have very sensitive skin or are sensitive to Salicylic Acid

    When using this product

    •  Avoid contact with eyes. If this happens, rinse thoroughly with water.
    •  If conditions worsens or does not improve after regular use of this product as directed, consult a physician.
    • Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
    •  If condition covers a large area of the body, consult your physician before using this product. Stop and ask a doctor if irritation becomes

    Stop and ask a doctor if

    irritation becomes severe

    Keep out of reach of children.

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

  • Directions

    • Cleanse the skin thoroughly before applying medication
    • Cover the entire affected area with athin layer one to three times a day.Because excessive drying of the skinmay occur, start with one applicationdaily, then gradually increase to 2 to 3times daily if needed or as directed bya doctor. If bothersome dryness orpeeling occurs, reduce application toonce a day or every other day.
  • Inactive ingredients:

    Aqua (Deionized Water), Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Isopropyl
    Myristate, Laureth-7, Maris Sal (Dead Sea) Salt, Phenoxyethanol, Polyacrylamide, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

  • Package Labeling:

    Psoriasis 5ml

  • INGREDIENTS AND APPEARANCE
    DUSEL PSORIASIS DEAD SEA SALT THERAPY 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70656-740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70656-740-015 mL in 1 PACKET; Type 0: Not a Combination Product04/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/26/2016
    Labeler - Nanovita One LLC (080217774)
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