FDA.reportPublic FDA data

RE-LEVE

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2025-05-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:01:51

Label at a glance#

ProductRE-LEVE
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains

Dosage and administration

Adult and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub until gel is absorbed, children under 2 years of age : consult your doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 4%

Purpose

OTC - PURPOSE SECTION

Purpose
External Analgesic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains

Warnings

WARNINGS SECTION

Keep out of reach of children.  For external use only. Avoid contact with eyes and mucous membranes, wounds or damaged skin.  Do not use with heating pads.

Stop uses and ask a doctor if: Conditions worsen, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub until gel is absorbed, children under 2 years of age: consult your doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, emu oil, citrus aurantium dulcis (orange) peel oil, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, sodium hydroxymethylglycinate

Questions or Comments?  Orders: 

OTC - QUESTIONS SECTION

Call toll-free:  1-844-303-0037, 155 NE Court St.-152, Prineville, OR, 97754.  www.allforu.org.  Alcohol-free product made in USA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-3242-42025-01-30C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-52025-01-30C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-42023-03-08C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-52023-03-08C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-42023-01-30C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-52023-01-30C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-42020-03-06C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-52020-03-06C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-42020-01-31C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula
61577-3242-52020-01-31C16284748780-19d75b9d0-74bf-f424-e053-dadaa90a57ceRé-LEVE Natural Analgesic Pain Relieving Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3242-4RE-LEVE113.6 g in 1 JARGEL113.66
61577-3242-5RE-LEVE113.6 g in 1 TUBEGEL113.66

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
61577-324261577-3242-4, 61577-3242-5

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
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
WATER059QF0KO0RIACT
CITRUS MAXIMA SEED083X55C543IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
ROSA DAMASCENA FLOWER OIL18920M3T13IACT
SODIUM CARBONATE45P3261C7TIACT
GLYCERINPDC6A3C0OXIACT
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT
LEMON OILI9GRO824LLIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
RE-LEVEMENTHOLSOMBRA COSMETICS INC.b4b39d79-0439-41e7-adca-e5ccb8f44e402025-05-29WarningsExact identifier
ndc (package): 61577-3242-4
ndc (package): 61577-3242-5
ndc (product): 61577-3242
ndc11 (package): 61577324204
ndc11 (package): 61577324205
spl id: 364d60f1-80e4-1ee1-e063-6394a90ab590
spl set id: b4b39d79-0439-41e7-adca-e5ccb8f44e40

Reported adverse events (FAERS/openFDA)#

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