FDA.reportPublic FDA data

BARE 40 ​ ​ SA urea gel

Manufacturer
Scientific Solutions Global, LLC
Effective date
2018-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:21

Label at a glance#

ProductBare 40 SA
Active ingredientUREA
Label structure10 sections

Dosage and administration

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

Storage and handling

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

UREA

OTC - PURPOSE SECTION

HEALS CORNS & CALLUSES

INDICATIONS & USAGE SECTION

SOOTHES ROUGH & DRY SKIN

SOFTEN NAILS

MOISTURIZING GEL

SAFETY WARNING:

WARNINGS SECTION

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

TEA TREE OIL, ALOE VERA, SALICYLIC ACID, CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE GLYCOL, EMULSIFIERS, TRIETHANOLAMINE, COCONUT OIL, PRESERVED WATER

STORAGE AND HANDLING SECTION

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

SPL UNCLASSIFIED SECTION

ENHANCED WITH GREEN TEA, ALOE VERA & TEA TREE OIL

MAXIMUM STRENGTH

VISIT US AT: SCISOLGLOBAL.COM

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
349352urea 40 % Topical GelPSN1
349352urea 0.4 MG/MG Topical GelSCD1
349352urea 40 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71718-003-012020-01-31C16284748780-19d75b9d0-68d7-f424-e053-dadaa90a57ceBARE 40 ​ ​ SA urea gel
71718-003-022020-01-31C16284748780-19d75b9d0-68d7-f424-e053-dadaa90a57ceBARE 40 ​ ​ SA urea gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71718-003-01Bare 40 SA113 g in 1 JARGEL1131
71718-003-02Bare 40 SA113 g in 1 JARGEL1131
71718-003-02Bare 40 SA2 in 1 PACKAGEGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71718-003BARE 40 SA (UREA) GEL [SCIENTIFIC SOLUTIONS GLOBAL, LLC]1Legacy NDC, 3 package rows20180202_9f162480-6e5d-4a7c-9da0-cccf7379b904.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71718-00371718-003-01, 71718-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WACTIB
TEA TREE OILVIF565UC2GIACT
ALOE VERA LEAFZY81Z83H0XIACT
SALICYLIC ACIDO414PZ4LPZIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
XANTHAN GUMTTV12P4NEEIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
COCONUT OILQ9L0O73W7LIACT
WATER059QF0KO0RIACT
TRIDECETH-10G624N6MSBAIACT

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
ac403f80-7a1e-4413-afa8-c6ba368f75e39f162480-6e5d-4a7c-9da0-cccf7379b9042018-01-17WarningsExact identifier
spl id: ac403f80-7a1e-4413-afa8-c6ba368f75e3
spl set id: 9f162480-6e5d-4a7c-9da0-cccf7379b904

Reported adverse events (FAERS/openFDA)#

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