UREMOL 20% CREAM- urea cream 
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 20% Cream

Active ingredient

Urea 20%

Inactive ingredients

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

Indications

Uremol helps relieve the symptoms of dry thickened skin conditions such as itchthyosis and xerosis. Directions-adult, apply up to two times per day on clean dry skin.Do not use on irritated or dammaged skin.Clean hands properly after application. Stop use if condition worsens.

Purpose

Uremol 20% helps relieve the symptoms of dry thickened skin conditions such as itchthyosis and xerosis.

Dosage and Administration

Uremol 20%- Directions-adult, apply up to two times per day on clean dry skin.Do not use on irritated or dammaged skin. 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, if you may notice rash, itchiness, irritation, pain, reddening, burning or discoloration of the skin, consult a healthcare practitioner. If too much is applied, irritation may occur. If irritation worsens or persists, discontinue temporarily. Consult a health care professional: if you are pregnant or breastfeeding, if symtoms worsen or last for more than 7 days or if using other topical product on your skin or for use beyond 1 month.

For external use only. Keep out of reach and sight of children.

Uremol 20

UREMOL 20% CREAM 
urea cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61344-455
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
CAPRYLIC ACID (UNII: OBL58JN025)  
TRICAPRIN (UNII: O1PB8EU98M)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61344-455-25100 g in 1 TUBE; Type 6: Drug/Biologic Combination05/31/2019
2NDC:61344-455-50225 g in 1 TUBE; Type 6: Drug/Biologic Combination05/31/2019
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(61344-455)

Revised: 11/2023
Document Id: 0a9c19bf-c110-d61f-e063-6294a90aeead
Set id: 8a2f32ae-cbb7-4fc0-e053-2995a90ab374
Version: 5
Effective Time: 20231120
 
Odan Laboratories Ltd