UREMOL- urea lotion 
Odan Laboratories Ltd

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.

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Uremol 10% Lotion

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.

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

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.

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.

Uremol lotion

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)

Revised: 12/2022
Document Id: eec8516e-27ac-d690-e053-2995a90a48d2
Set id: 8a336cf1-2739-55b3-e053-2995a90a6d29
Version: 4
Effective Time: 20221201
 
Odan Laboratories Ltd