Uremol 10% Lotion

Manufacturer
Odan Laboratories Ltd
Effective date
2022-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:45:47

Label at a glance#

ProductUremol
Active ingredientUREA
Label structure8 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Urea 10%

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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.

OTC - PURPOSE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warning

WARNINGS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Uremol lotionUremol lotion

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61344-45261344-452-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f82b7537-3f29-420a-a964-18680ea5c4d18a336cf1-2739-55b3-e053-2995a90a6d292024-06-10WarningsExact identifier
spl set id: 8a336cf1-2739-55b3-e053-2995a90a6d29

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.