Label: UREACREAM- urea cream

  • NDC Code(s): 84019-009-01
  • Packager: Shengnan (Guangzhou) Cosmetics Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!