Label: DERMELEVE- pramoxine hydrochloride cream

  • NDC Code(s): 81507-005-01, 81507-005-02
  • Packager: Advanced Derm Solutions LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 16, 2024

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  • Active Ingredient

    Pramoxine Hydrochloride (1%)

  • Purpose

    External analgesic

  • Uses

    For temporary relief of pain and itching associated with skin irritations, minor burns, sunburn, and rashes due to poison ivy, poison oak, or poison sumac

  • Warnings

    • For external use only.
    • Avoidcontact with eyes. 
    • Do not apply to open wounds. 
    • STOP USE and ask a doctor if condition worsens or symptoms persist for more than seven days. 
    • Keep out of reach of children.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children two years of age and older, apply to affected area as needed or as directed by a doctor.

    Consult a doctor for children under the age of two.

  • SPL UNCLASSIFIED SECTION

    Store at 20-25ºC (68-77ºF). Keep carton for full product information

  • SPL UNCLASSIFIED SECTION

    Questions? Visit www.dermeleve.com or call +1 (877)-684-2299

  • Inactive ingredients

    Ascorbyl Tetraispalmitate, Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol
    Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 60, Propylene Glycol, Sodium Hyaluronate, Strontium Nitrate, Tocopherol Acetate (Vitamin E), Water, Xanthan Gum

  • Product label

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  • INGREDIENTS AND APPEARANCE
    DERMELEVE 
    pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81507-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    WATER O-18 (UNII: 7QV8F8BYNJ)  
    MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STRONTIUM NITRATE (UNII: BDG873AQZL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81507-005-011 in 1 BOX11/01/2024
    160 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:81507-005-021 in 1 BOX11/01/2024
    2120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/01/2024
    Labeler - Advanced Derm Solutions LLC (117840544)
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