Urea 20

Manufacturer: Scientific Solutions Global LLC
Effective date: 2019-09-27
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:00:36

Label at a glance#

ProductUrea 40 Plus HA

Active ingredientUREA

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UreaHA

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

UREA

OTC - PURPOSE SECTION

SOOTHES ROUGH & DRY SKIN

HEALS CORNS & CALLOUSES

SOFTENS NAILS

INDICATIONS & USAGE SECTION

SOOTHES ROUGH & DRY SKIN

SAFE HANDLING WARNING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

INSTRUCTIONS FOR USE SECTION

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.

INACTIVE INGREDIENT SECTION

ALOE VERA, CARBOMER, COCONUT OIL, EMULSIFIERS, GREEN TEA, MINERAL OIL, PRESERVED WATER, POPYLENE GLYCOL, SODIUM HYALURONATE, TEA TREE OIL, TRIETHANOLOAMINE, XANTHAM GUM

STORAGE AND HANDLING SECTION

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

OTHER SAFETY INFORMATION

ENHANCED WITH TEA TREE OIL & ALOE VERA

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0653981752125	GTIN-13: 0653981752125 EAN-13: 0653981752125 GTIN-12: 653981752125 UPC-A: 653981752125 GTIN storage (14 digits): 00653981752125	UREA 40 Outlines-1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71718-213-01	2021-01-29	C162847	48780-1	ba0f9c33-1dfc-a910-e053-dadaa90a0b85	92fda608-031c-5f84-e053-2995a90a96c0
71718-213-02	2021-01-29	C162847	48780-1	ba0f9c33-1dfc-a910-e053-dadaa90a0b85	92fda608-031c-5f84-e053-2995a90a96c0
71718-213-03	2021-01-29	C162847	48780-1	ba0f9c33-1dfc-a910-e053-dadaa90a0b85	92fda608-031c-5f84-e053-2995a90a96c0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71718-213-01	Urea 40 Plus HA	113 g in 1 JAR	GEL	113	4
71718-213-02	Urea 40 Plus HA	113 g in 1 BOTTLE, DISPENSING	GEL	113	4
71718-213-03	Urea 40 Plus HA	226 g in 1 BOTTLE, DISPENSING	GEL	226	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71718-213	UREA 40 PLUS HA (UREA) GEL [SCIENTIFIC SOLUTIONS GLOBAL LLC]	4	Legacy NDC, 3 package rows	20190928_92fda608-031c-5f84-e053-2995a90a96c0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Urea 40 Plus HA
Urea
CARBOXYPOLYMETHYLENE
XANTHAN GUM
MINERAL OIL
COCONUT OIL
WATER
TRIDECETH-10
TEA TREE OIL
PROPYLENE GLYCOL
ALOE VERA LEAF
HYALURONATE SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71718-213	71718-213-01, 71718-213-02, 71718-213-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
XANTHAN GUM	TTV12P4NEE	IACT
MINERAL OIL	T5L8T28FGP	IACT
COCONUT OIL	Q9L0O73W7L	IACT
WATER	059QF0KO0R	IACT
TRIDECETH-10	G624N6MSBA	IACT
TEA TREE OIL	VIF565UC2G	IACT
UREA	8W8T17847W	ACTIB
PROPYLENE GLYCOL	6DC9Q167V3	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
938b8785-ae66-8865-e053-2995a90a5e78			92fda608-031c-5f84-e053-2995a90a96c0	2019-09-27	Warnings	Exact identifier spl id: 938b8785-ae66-8865-e053-2995a90a5e78 spl set id: 92fda608-031c-5f84-e053-2995a90a96c0

Reported adverse events (FAERS/openFDA)#

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