FDA.reportPublic FDA data

Bare 40

Manufacturer
SSG Ventures Inc
Effective date
2021-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:02

Label at a glance#

ProductBare 40
Active ingredientUREA
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

OTC - ACTIVE INGREDIENT SECTION

Urea 40%

OTC - PURPOSE SECTION

SOOTHES ROUGH & DRY SKIN

WORKS ON CORNS & CALLUSES

SOFTENS NAILS

INDICATIONS & USAGE SECTION

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED

SAFE HANDLING WARNING SECTION

SAFETY WARNING:

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN. STOP USE IF CONDITION WORSENS OR CLEARS UP AND REOCCURS

STORAGE AND HANDLING SECTION

KEEP LID FIRMLY CLOSED. STORE IN A COOL DRY PLACE

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

APPLY TO AFFECTED AREA AT LEAST TQICE DAILY OR AS NEEDED

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81376-221-012023-01-30C16284748780-1f386c64a-34ee-0266-e053-dadaa90a7c1aBare 40
81376-221-022023-01-30C16284748780-1f386c64a-34ee-0266-e053-dadaa90a7c1aBare 40
81376-221-032023-01-30C16284748780-1f386c64a-34ee-0266-e053-dadaa90a7c1aBare 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81376-221-01Bare 40113 g in 1 JARGEL1131
81376-221-02Bare 40113 g in 1 BOTTLE, DISPENSINGGEL1131
81376-221-03Bare 40226 g in 1 BOTTLE, DISPENSINGGEL2261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81376-221BARE 40 (UREA) GEL [SSG VENTURES INC]1Legacy NDC, 3 package rows20210211_baec5c4c-3c7d-464a-e053-2995a90a7a2e.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81376-22181376-221-01, 81376-221-02, 81376-221-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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

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
baec5c4c-3c7e-464a-e053-2995a90a7a2ebaec5c4c-3c7d-464a-e053-2995a90a7a2e2021-02-09WarningsExact identifier
spl id: baec5c4c-3c7e-464a-e053-2995a90a7a2e
spl set id: baec5c4c-3c7d-464a-e053-2995a90a7a2e

Reported adverse events (FAERS/openFDA)#

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