Urea 20 - DailyMed Details

Urea 20

SPL v2

SPL

SPL Set ID b7112eb7-2ec1-8b17-e053-2995a90a4e1b

Route

TOPICAL

Published

Effective Date 2019-09-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Urea (20 g)

Inactive Ingredients

Trolamine Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Xanthan Gum Mineral Oil Coconut Oil Water Tea Tree Oil Propylene Glycol Propylparaben Methylparaben

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2019-09-20

Description

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

Medication Information

Description

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

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Section 55105-1

REDUCES CORNS & CALLUSES

Section 55106-9

UREA

Directions

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR

AS NEEDED. USE CONTINUOUSLY FOR 2-3 WEEKS FOR

OPTIMAL RESULTS.

Directions:

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

Indications:

SOOTHES ROUGH & DRY SKINSOFTEN NAILSMOISTURIZING GEL

Safety Warning :

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

Active Ingredients

UREA 20%

Inactive Ingredients

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

Structured Label Content

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

REDUCES CORNS & CALLUSES

Section 55106-9 (55106-9)

UREA

Directions

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR

AS NEEDED. USE CONTINUOUSLY FOR 2-3 WEEKS FOR

OPTIMAL RESULTS.

Directions: (DIRECTIONS:)

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

Indications:

SOOTHES ROUGH & DRY SKINSOFTEN NAILSMOISTURIZING GEL

Safety Warning : (SAFETY WARNING :)

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

Active Ingredients

UREA 20%

Inactive Ingredients

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

Advanced Ingredient Data

[{"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UREA", "unii": "8W8T17847W", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"50565-1": "KEEP OUT OF REACH OF CHILDREN.", "55105-1": "REDUCES CORNS & CALLUSES", "55106-9": "UREA", "Directions": "APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED. USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.", "DIRECTIONS:": "APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.", "Indications:": "SOOTHES ROUGH & DRY SKINSOFTEN NAILSMOISTURIZING GEL", "SAFETY WARNING :": "FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.", "Active Ingredients": "UREA 20%", "Inactive Ingredients": "PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAN GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:35.473908 · Updated: 2026-03-14T22:59:37.411151