Label: DERMELEVE ANTI ITCH SCALP SERUM- aluminum acetate solution

  • NDC Code(s): 81507-004-01
  • Packager: Advanced Derm Solutions LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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  • Active Ingredient

    Aluminum acetate (0.2%)

  • Purpose

    Astringent

  • Uses

    Scalp itch; rashes caused by soaps, detergent, or cosmetics

  • Warnings

    For external use only. Avoidcontact with eyes. Do not applyto open wounds. STOP USEand 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. Twist the flow-control cap to open. Apply directly to scalp, rub in if needed. 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 877-684-2299

  • Inactive ingredients

    Butylene Glycol, Calcium Chloride, Caprylyl Glycol, Disodium EDTA, Glycerin, Lactic Acid, Niacinamide, Phenoxyethanol, Polysorbate 80, Strontium Nitrate, Water, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DERMELEVE ANTI ITCH SCALP SERUM 
    aluminum acetate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81507-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STRONTIUM NITRATE (UNII: BDG873AQZL)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81507-004-0189 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/02/2023
    Labeler - Advanced Derm Solutions LLC (117840544)
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