Uremol 10%

Manufacturer
Odan Laboratories LTD
Effective date
2019-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:23:17

Label at a glance#

ProductUremol 10%
Active ingredient(4-(TRIFLUOROMETHOXY)PHENYL)UREA
Label structure8 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Urea 100mg/g

Inactive ingredient

INACTIVE INGREDIENT SECTION

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

Indication

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION

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

Administration

DOSAGE & ADMINISTRATION SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warning

WARNINGS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Uremol 10Uremol 10

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61344-45061344-450-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
8a719737-9992-24be-e053-2995a90a8cd98a0609fe-3861-ea0b-e053-2995a90a06dd2019-06-03WarningsExact identifier
spl set id: 8a0609fe-3861-ea0b-e053-2995a90a06dd

Reported adverse events (FAERS/openFDA)#

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