Uremol 10% by Odan Laboratories LTD / Odan Laboratories Ltd

Uremol 10% by

Drug Labeling and Warnings

Uremol 10% 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]

UREMOL 10%- 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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Active ingredient

Urea 100mg/g

Inactive ingredient

Cyclomethicone, dimethicone copolyol, dimethicone, cyclomethicone, diazolidinyl urea, purified water, lauryl PEG/PPG-18, , methicone, methylparaben, propylene glycol, propylparaben, synthetic wax, white petrolatum.

Indication

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

Purpose

Urimol protects and helps relieve minor skin irritation and itching. . Store between 15- 300 C.

Administration

Uremol 10 % temporarily protects and helps relieve minor skin irritation and itching. Apply up to 3 times/day. Do not use on children under 2 years old, unless directed by a physician. Used on children should be supervised by an adult

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

Warning

Stop use if condition worsens.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 10% 
urea cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61344-450
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
(4-(TRIFLUOROMETHOXY)PHENYL)UREA (UNII: SQP4E8O29W) ((4-(TRIFLUOROMETHOXY)PHENYL)UREA - UNII:SQP4E8O29W)	(4-(TRIFLUOROMETHOXY)PHENYL)UREA	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL 1-STEARATE (UNII: 32I3MRN561)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61344-450-25	100 g in 1 TUBE; Type 6: Drug/Biologic Combination	05/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/29/2019	05/30/2019

Labeler - Odan Laboratories LTD (208585604)

Establishment
Name	Address	ID/FEI	Business Operations
Odan Laboratories Ltd		208585604	manufacture(61344-450)

Revised: 6/2019

Document Id: 8a719737-9992-24be-e053-2995a90a8cd9

34390-5

Set id: 8a0609fe-3861-ea0b-e053-2995a90a06dd

Version: 3

Effective Time: 20190603