Uremol by Odan Laboratories Ltd / Odan Laboratories LTD UREMOL- urea lotion

Uremol by

Drug Labeling and Warnings

Uremol by is a Otc medication manufactured, distributed, or labeled by Odan Laboratories Ltd, Odan Laboratories LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

UREMOL 
urea lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61344-452
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61344-452-30	250 mL in 1 BOTTLE; Type 6: Drug/Biologic Combination	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/31/2019

Labeler - Odan Laboratories Ltd (208585604)

Establishment
Name	Address	ID/FEI	Business Operations
Odan Laboratories LTD		208585604	manufacture(61344-452)