Label: UREMOL- urea lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 1, 2022

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  • Active ingredient

    Urea 10%

  • Inactive ingredients

    Caprylic, Caprylic triglyceride, carbomer 940, ceteareth-12, ceteareth-20, citrid acid, diazolidinyl urea, purified water, glycerin, xanthan gum, methylparaben, glyceryl monostearate, octyldodecanol, sodium phosphate dibasic, potassium phosphate monobasic, propylene glycol, propylparaben,

  • Indication and usage

    Uremol temporarily protects and helps relieve minor skin irritation and itching. Apply to skin up to 3 times/day. Do not use under 2 years old, unless directed by a physician. Used on children should be supervised by an adult. Stop use if condition worsens.

  • PURPOSE

    Uremol 10% lotion temporarily protects and helps relieve minor skin irritation and itching..

  • DOSAGE & ADMINISTRATION

    Uremol 10 % temporarily protects and helps relieve minor skin irritation and itching. Apply to skin up to 3 times/day. Do not use on children under 2 years old.

  • KEEP OUT OF REACH OF CHILDREN

    For external use only. Keep out of reach and sight of children. Store between 15-30 0C.

  • Warning

    Don't use if allergic to urea or any other ingredients in Uremol. Avoid contact with eyes and mucous membrane; in case of contact, wash with water. After application you may notice rash, itchiness, irritation, pain, reddening, burning or discoloration of the skin, which could be sign of an allergic reaction. Stinging may occur if applied to damaged skin. If too much is applied, irritation may occur. If irritation worsens or persists, discontinue temporarily. Consult a health care professional if symtoms worsen or last for more than 7 days or if using other topical product on your skin.

  • PRINCIPAL DISPLAY PANEL

    Uremol lotion

  • INGREDIENTS AND APPEARANCE
    UREMOL 
    urea lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61344-452
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    TRICAPRILIN (UNII: 6P92858988)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61344-452-30250 mL in 1 BOTTLE; Type 6: Drug/Biologic Combination05/31/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/31/2019
    Labeler - Odan Laboratories Ltd (208585604)
    Establishment
    NameAddressID/FEIBusiness Operations
    Odan Laboratories LTD208585604manufacture(61344-452)