Label: UREACREAM- urea cream

  • NDC Code(s): 84019-009-01
  • Packager: Shengnan (Guangzhou) Cosmetics Co., LTD
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 18, 2024

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  • WARNINGS

    For externnl use only.Avoid direct contact with eyes

  • PURPOSE

    Improves the texture of foot akin, reduicing roughness and making it smoother and more refined.

  • USE SECTION

    Stop use and ask doctor if rash occurs.

  • ACTIVE INGREDIENT

    Urea 40%

  • WHEN USING SECTION

    Do not apply to wounds or damaged skin

  • INACTIVE INGREDIENT

    Water
    Beeswax

    Glycerin

    Salicylic Acid

    Butyrospermum Parkii （Shea） Butter
    Dimethicone

    Caprylic/Capric Triglyceride
    Cetearyl Alcohol

    Propylene Glycol
    Fragrance
    Phenoxyethanol
    Palmitic Acid

    Stearic Acid
    Tocopherol
    Panthenol

  • DOSAGE & ADMINISTRATION

    Apply 1-2 times a day

  • INDICATIONS & USAGE

    Gently clean the slin let it dry.Apply cream to theafected area. Gendy massage until fullyabsorbed

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    UREACREAM 
    urea cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84019-009
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA (UNII: 0214C2T14J) (1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA - UNII:0214C2T14J) 1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    BEESWAX (UNII: 2ZA36H0S2V)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84019-009-0140 g in 1 BOTTLE; Type 0: Not a Combination Product11/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/18/2024
    Labeler - Shengnan (Guangzhou) Cosmetics Co., LTD (541200425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengnan (Guangzhou) Cosmetics Co., Ltd541200425manufacture(84019-009)
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