Urea 40

Urea 40
SPL v3
SPL
SPL Set ID b71138ef-3166-d690-e053-2995a90a92d2
Route
TOPICAL
Published
Effective Date 2019-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Urea (4 g)
Inactive Ingredients
Methylparaben Propylparaben Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Xanthan Gum Mineral Oil Coconut Oil Water Trolamine Tea Tree Oil Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-04-01
Description

UREA 40%

Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

Indications and Usage

SOOTHES ROUGH & DRY SKIN

Dosage and Administration

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

Description

UREA 40%

Section 44425-7

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 50741-8

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

Section 51727-6

PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAM GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN

Section 51945-4

Section 55105-1

SOOTHES ROUGH & DRY SKIN

HEALS CORNS & CALLOUSES

Section 59845-8

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

Section 60561-8

ENHANCED WITH TEA TREE OIL & ALOE VERA

Active Ingredients:

UREA 40%

Structured Label Content

Indications and Usage (34067-9)

SOOTHES ROUGH & DRY SKIN

Dosage and Administration (34068-7)

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

Section 44425-7 (44425-7)

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 50741-8 (50741-8)

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

Section 51727-6 (51727-6)

PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAM GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

SOOTHES ROUGH & DRY SKIN

HEALS CORNS & CALLOUSES

Section 59845-8 (59845-8)

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

Section 60561-8 (60561-8)

ENHANCED WITH TEA TREE OIL & ALOE VERA

Active Ingredients: (ACTIVE INGREDIENTS:)

UREA 40%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:35.475042 · Updated: 2026-03-14T22:59:37.411151