Urea 40 Nail Gel

SPL v2

SPL

SPL Set ID b711b6b3-f4f4-2f76-e053-2a95a90aa815

Route

TOPICAL

Published

Effective Date 2019-10-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Urea (12 g)

Inactive Ingredients

Water Dimethyl Sulfoxide Hydroxyethyl Cellulose (100 Mpa.s At 2%)

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2019-10-07

Description

Urea

Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY.

AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN

STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS US AND REOCCURS

Indications and Usage

WITH THE POWER OF UREA, THIS NAIL GEL REDUCES NAIL THICKNEDD AND PROTECTS THE NAIL FROM FUNGAL GROWTH WHILE CLEARING THE REMNANTS FROM THE NAIL BED.

SMOOTHS ANS EXFOLIATES NAILS.

SUITABLE FOR FINGERNAILS AND TOENAILS.

Dosage and Administration

APPLY TO AFFECTED NAILS AT LEAST TWICE DAILY OR AS NEEDED

Description

Urea

Section 44425-7

KEEP LID FIRMLY CLOSED

CLOSED IN A 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 A DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS

KEEP LID FIRMLY CLOSED.

CLOSED IN A COOL DRY PLACE

Section 51727-6

HYDROXYETHYL CELLULOSE NF, PURIFIED WATER, DIMETHYL SULFOXIDE USP

Section 51945-4

Section 55105-1

FOR DAMAGED & THICKENED NAILS

ANTI-FUNGAL

Section 55106-9

Urea

Structured Label Content

Indications and Usage (34067-9)

WITH THE POWER OF UREA, THIS NAIL GEL REDUCES NAIL THICKNEDD AND PROTECTS THE NAIL FROM FUNGAL GROWTH WHILE CLEARING THE REMNANTS FROM THE NAIL BED.

SMOOTHS ANS EXFOLIATES NAILS.

SUITABLE FOR FINGERNAILS AND TOENAILS.

Dosage and Administration (34068-7)

APPLY TO AFFECTED NAILS AT LEAST TWICE DAILY OR AS NEEDED

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY.

AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN

STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS US AND REOCCURS

Section 44425-7 (44425-7)

KEEP LID FIRMLY CLOSED

CLOSED IN A 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 A DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS

KEEP LID FIRMLY CLOSED.

CLOSED IN A COOL DRY PLACE

Section 51727-6 (51727-6)

HYDROXYETHYL CELLULOSE NF, PURIFIED WATER, DIMETHYL SULFOXIDE USP

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

FOR DAMAGED & THICKENED NAILS

ANTI-FUNGAL

Section 55106-9 (55106-9)

Urea

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHYL SULFOXIDE", "unii": "YOW8V9698H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)", "unii": "R33S7TK2EP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UREA", "unii": "8W8T17847W", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "12", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "WITH THE POWER OF UREA, THIS NAIL GEL REDUCES NAIL THICKNEDD AND PROTECTS THE NAIL FROM FUNGAL GROWTH WHILE CLEARING THE REMNANTS FROM THE NAIL BED. SMOOTHS ANS EXFOLIATES NAILS. SUITABLE FOR FINGERNAILS AND TOENAILS.", "34068-7": "APPLY TO AFFECTED NAILS AT LEAST TWICE DAILY OR AS NEEDED", "34071-1": "FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS US AND REOCCURS", "44425-7": "KEEP LID FIRMLY CLOSED CLOSED IN A COOL DRY PLACE", "50565-1": "KEEP OUT OF REACH OF CHILDREN", "50741-8": "FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS KEEP LID FIRMLY CLOSED. CLOSED IN A COOL DRY PLACE", "51727-6": "HYDROXYETHYL CELLULOSE NF, PURIFIED WATER, DIMETHYL SULFOXIDE USP", "55105-1": "FOR DAMAGED & THICKENED NAILS ANTI-FUNGAL", "55106-9": "Urea"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:23.102613 · Updated: 2026-03-14T22:59:19.689823