FDA.reportPublic FDA data

OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEF CREAM

Manufacturer
OWELL NATURAL 8 LLC
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-31 05:10:06

Label at a glance#

ProductOWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEF
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains.

Dosage and administration

Adults and children 2 years of age and older: apply to affected area

Label contents#

Full prescribing information#

Directions for use

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply to affected area

Uses/claims

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 8%

General safety warnings

WARNINGS SECTION

For external use only. Do not use in eyes

Contraindications

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Pre-existing conditions requiring medical consultation.

Precautions

OTC - WHEN USING SECTION

Avoid contact with eyes", "Do not bandage tightly

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis Leaf Juice, Beeswax, Hydrogenated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride, Dimethyl Sulfone (MSM), Arnica Montana, Pyridoxine Hydrochloride (Vitamin B6), and Tocopherol (Vitamin E).

Principal Display Panel - Leg Pain Relief Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1leg cream2ozleg cream2ozleg cream4ozleg cream4oz

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850057105742GTIN-13: 0850057105742
EAN-13: 0850057105742
GTIN-12: 850057105742
UPC-A: 850057105742
GTIN storage (14 digits): 00850057105742		LegPainCream-2oz.jpg
BarcodeEAN-130850057105766GTIN-13: 0850057105766
EAN-13: 0850057105766
GTIN-12: 850057105766
UPC-A: 850057105766
GTIN storage (14 digits): 00850057105766		Leg Cream 4oz (1).jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83570-00883570-008-01, 83570-008-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
SAFFLOWER OIL65UEH262ISIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EUCALYPTUS OIL2R04ONI662IACT
SUNFLOWER OIL3W1JG795YIIACT
CAMPHOR OIL75IZZ8Y727IACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ARNICA MONTANAO80TY208ZWIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT

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
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
ndc (package): 83570-008-01
ndc (package): 83570-008-02
ndc (product): 83570-008
ndc11 (package): 83570000801
ndc11 (package): 83570000802
spl id: 57a124b4-66c7-2474-e063-6294a90ab0d7
spl set id: 57a124b4-66c6-2474-e063-6294a90ab0d7

Reported adverse events (FAERS/openFDA)#

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