OWELL NATURALS Deep Penetrating Pain Relief Ointment

Manufacturer
OWELL NATURALS BRAND, LLC
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:06:49

Label at a glance#

ProductOWELL NATURALS Deep Penetrating Pain Relief
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.  Provides cooling pain relief.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.66%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 
  • Provides cooling pain relief.

Warnings

WARNINGS SECTION

For External Use Only.

Do Not Use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove
  • Do not bandage tightly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age: consult a doctor.

Other information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Camphor, Eucalyptus Globulus Oil, Methyl Salicylate, Petrolatum, Pinus Palustris Pine) Oil

Questions?

OTC - QUESTIONS SECTION

Customer Care: 1.800.203.9451

Package Labeling: 60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 103.5ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 207ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3
Label3

Package Labeling: 414ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4
Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672826menthol 7.66 % Topical OintmentPSN1
2672826menthol 0.0766 MG/MG Topical OintmentSCD1
2672826menthol 7.66 % Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83570-443-02OWELL NATURALS Deep Penetrating Pain Relief60 mL in 1 JAROINTMENT601
83570-443-03OWELL NATURALS Deep Penetrating Pain Relief103.5 mL in 1 JAROINTMENT103.51
83570-443-07OWELL NATURALS Deep Penetrating Pain Relief207 mL in 1 JAROINTMENT2071
83570-443-14OWELL NATURALS Deep Penetrating Pain Relief414 mL in 1 JAROINTMENT4141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83570-443OWELL NATURALS DEEP PENETRATING PAIN RELIEF (MENTHOL) OINTMENT [OWELL NATURALS BRAND, LLC]1Current NDC, 4 package rows20240108_b36eb017-ed8d-476e-994b-22b275e00543.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83570-44383570-443-02, 83570-443-03, 83570-443-07, 83570-443-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
OWELL NATURALS Deep Penetrating Pain ReliefMENTHOLOWELL NATURALS BRAND, LLCb36eb017-ed8d-476e-994b-22b275e005432024-01-02WarningsExact identifier
ndc (package): 83570-443-14
ndc (package): 83570-443-07
ndc (package): 83570-443-02
ndc (package): 83570-443-03
ndc (product): 83570-443
ndc11 (package): 83570044303
ndc11 (package): 83570044307
ndc11 (package): 83570044302
ndc11 (package): 83570044314
spl id: 0dba3e8a-1315-7ab3-e063-6394a90a8a6a
spl set id: b36eb017-ed8d-476e-994b-22b275e00543

Reported adverse events (FAERS/openFDA)#

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