Owell Naturals Pain Relief Cream

Manufacturer
Owell Naturals Brand LLC
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:13

Label at a glance#

ProductOwell Naturals Pain Relief Cream
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 8%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome

WARNINGS SECTION

Warnings
For External Use Only.
Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using.
Do Not Use
■ on wounds or damaged skin ■ with a heating pad
■ on a child under 12 years of age with arthritis-like conditions
Ask a doctor before use if you have redness over the affected area.
When Using This Product ■ avoid contact with eyes or other sensitive areas ■ do not bandage tightly

Stop use and ask a doctor if
■ condition worsens or symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive skin irritation occurs
Keep out of reach of children to avoid accidental ingestion. If swal- lowed, get medical help or contact
a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions ■ use only as directed
■ adults and children 12 years of age and older: apply to affected area
■ children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Carthamus tinctorius (Hybrid Safflower) Seed Oil, Helianthus annuus (Sunflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe barbadensis (Aloe Vera) Leaf Juice, Beeswax, Hydro- genated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus globulus Leaf Oil, Chlorphenesin, Cinnamomum camphora Bark Oil, Abies sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Owell Pain Relief CreamOwell Pain Relief Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
727161menthol 8 % Topical CreamPSN1
727161menthol 80 MG/ML Topical CreamSCD1
727161menthol 8 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83570-500-02Owell Naturals Pain Relief Cream60 mL in 1 JARCREAM601
83570-500-03Owell Naturals Pain Relief Cream103.5 mL in 1 JARCREAM103.51
83570-500-07Owell Naturals Pain Relief Cream207 mL in 1 JARCREAM2071
83570-500-14Owell Naturals Pain Relief Cream414 mL in 1 JARCREAM4141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83570-500OWELL NATURALS PAIN RELIEF CREAM (MENTHOL) CREAM [OWELL NATURALS BRAND LLC]14 package rows20240929_231e60ab-7044-3911-e063-6394a90a685e.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
83570-50083570-500-02, 83570-500-03, 83570-500-07, 83570-500-14

Ingredients#

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

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

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
231e60ab-7045-3911-e063-6394a90a685e231e60ab-7044-3911-e063-6394a90a685e2024-09-27WarningsExact identifier
spl id: 231e60ab-7045-3911-e063-6394a90a685e
spl set id: 231e60ab-7044-3911-e063-6394a90a685e

Reported adverse events (FAERS/openFDA)#

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