Owell Naturals Pain Relief Cream

Manufacturer
Amish Origins LLC
Effective date
2023-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:38

Label at a glance#

ProductMenthol
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

​Adults and children over 12 years: ​Apply freely to affected areas. Rub well ​Colds: ​Apply on chest, back and neck. ​Head Colds : Apply around nostrils, on forehead and behind ears.  Place small amount in vaporizer for aid. ​Sore Throat: ​ Apply  liberally on throat and neck for sore throats Children 12 years or younger. Consult your physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 8%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For External Use Only, As Directed!
  • Avoid contact with eyes or other sensitive areas.
  • If prone to allergic reaction from asprin or salicylate, consult your doctor before using.
  • If conditions persist pore than seven days, consult your doctor
  • If pregnant or breast-feeding, ask a health professional before use.
  • Do not bandange tightly or use a heating pad
  • May irritate sensitive skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep ointment out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

​Adults and children over 12 years:

  • ​Apply freely to affected areas. Rub well
  • ​Colds: ​Apply on chest, back and neck.
  • ​Head Colds: Apply around nostrils, on forehead and behind ears.  Place small amount in vaporizer for aid.
  • ​Sore Throat:​ Apply  liberally on throat and neck for sore throats

Children 12 years or younger.

  • Consult your physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis (Aleo Vera) Leaf Juice, Beeswax, Hydrogenated Castor oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Chlorphenesin, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7FL OZ Pain Relief Cream label7FL OZ Pain Relief Cream label

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62212-505-012025-01-30C16284748780-12cef2736-ae57-d83d-e063-dadaa90ab31fOwell Naturals Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62212-505-01Menthol198.45 g in 1 JARCREAM198.451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62212-505MENTHOL (OWELL NATURALS PAIN RELIEF CREAM) CREAM [AMISH ORIGINS LLC]11 package rows20230718_00b14e55-eddf-653d-e063-6394a90a3258.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62212-50562212-505-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
00b14e55-ede0-653d-e063-6394a90a325800b14e55-eddf-653d-e063-6394a90a32582023-07-17WarningsExact identifier
spl id: 00b14e55-ede0-653d-e063-6394a90a3258
spl set id: 00b14e55-eddf-653d-e063-6394a90a3258

Reported adverse events (FAERS/openFDA)#

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