FDA.reportPublic FDA data

RE-LEVE FOOTLUBE PAIN RELIEF

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:51:54

Label at a glance#

ProductRE-LEVE FOOTLUBE PAIN RELIEF
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Detoxifies joints, relieves sore feet, athletes foot, foot odor, perspiration and coldness. Soothes and relieves pain after long hours of standing on feet.

Dosage and administration

Apply before putting on socks and shoes.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 3%

Purpose

OTC - PURPOSE SECTION

Purpose
External Analgesic

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of the reach of children

Uses

INDICATIONS & USAGE SECTION

Detoxifies joints, relieves sore feet, athletes foot, foot odor, perspiration and coldness. Soothes and relieves pain after long hours of standing on feet.

Warnings

WARNINGS SECTION

Keep out of the reach of children. For external use only. Aviod contact with eyes and mucous membranes, wounds or damaged skin. Store at room temperature. Do not use with heating pads. If symtoms do not respond within one week, see doctor. ReLEVE Products makes no medical claims.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply before putting on socks and shoes.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Carbomer, Yellow #5 Colorant, Blue #1 Colorant, Hamamelis Viriniana Leaf Extract, Yucca Schidigera Stem/Root Extract, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Vegetable Glycerin, Aloe Barbadensis Leaf Juice, Emu Oil, Simmondsia Chinensis (Jojoba) Seed oil, Phenoxyethanol, Germanium oil, Caprylyl Glycol, Sodium Carbonate.

Questions or Comments?

OTC - QUESTIONS SECTION

Call Toll Free: 1-866-673-5383, 6070 S. Eastern Ave. Suite 210, Las Vegas, NV 89119, www.reskincare.com

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259150menthol 3 % Topical GelPSN8
259150menthol 0.03 MG/MG Topical GelSCD8
259150menthol 3 % Topical GelSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-5042-52025-01-30C16284748780-12cef2736-8278-d83d-e063-dadaa90ab31fRe-LEVE Footlube Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-5042-5RE-LEVE FOOTLUBE PAIN RELIEF118 g in 1 TUBEGEL1188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-5042RE-LEVE FOOTLUBE PAIN RELIEF (MENTHOL) GEL [SOMBRA COSMETICS INC.]8Legacy NDC, 1 package rows20221129_ccbb5806-cec7-4755-b714-8139aef2d02a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-504261577-5042-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
WITCH HAZEL101I4J0U34IACT
YUCCA SCHIDIGERA STEMN59C6T6D72IACT
GRAPEFRUIT SEED OIL598D944HOLIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
EMU OIL344821WD61IACT
JOJOBA OIL724GKU717MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MENTHOLL7T10EIP3AACTIB

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
74d847cf-8bd2-4705-9d63-5bfccd766ee8ccbb5806-cec7-4755-b714-8139aef2d02a2022-11-28WarningsExact identifier
spl id: 74d847cf-8bd2-4705-9d63-5bfccd766ee8
spl set id: ccbb5806-cec7-4755-b714-8139aef2d02a

Reported adverse events (FAERS/openFDA)#

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