FDA.reportPublic FDA data

DR JOE LAB PMS Menstrual Pain Relief Oil

Manufacturer
Dr Joe Lab, Inc.
Effective date
2022-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:19

Label at a glance#

ProductDR JOE LAB PMS Menstrual Pain Relief Oil
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

Indications and uses

Temporarily relieves minor pain associated with menstrual cramps.

Dosage and administration

Adults and children over 12 years of age: • apply to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 times daily.

Storage and handling

Protect the product in this container from excessive heat and direct sun. Store at 20-25°C (66-77°F).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.4%
Methyl Salicylate 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with menstrual cramps.

Warnings

WARNINGS SECTION

For external use only

When using this product
• use only as directed
• avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged skin

Stop use and ask a doctor if
• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops.

Allergy Alert
Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age:
• apply to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 times daily.

Other Information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun. Store at 20-25°C (66-77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Vitamin E, Butylated Hydroxytoluene, Isopropyl Myristate, Eucalyptus Leaf Oil.

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-349-7735 or visit www.drjoelab.com to report serious adverse events associated with use of the product.

SPL UNCLASSIFIED SECTION

Temporary relief of monthly feminine discomfort

Fast Acting

Long Lasting

Pain Relief

Dr Joe Lab PMS Menstrual Pain Relief Oil is a safe and highly effective topical analgesic specifically designed to relieve menstrual pain.

• Fast Acting
• Safe For Women
• Applies Easily
• Absorbs Quickly
• Won’t Stain Clothes
• Soft Pleasant Scent

All Natural Menstrual Cramps Relief

It is safe to use for all women regardless of the severity of their discomfort.

The all-natural plant extracts in this oil help to temporary relieve pain associated with menstrual cramps.

There's no harm in putting a little oil in your belly button. Just don't press down too hard on your belly button, as there's a large amount of nerves around your gut, and the pressure could be painful.

Manufactured by
Despina Pharma Inc
Distributed by
Dr Joe Lab Inc
1720E Garry Ave, Ste 119
Santa Ana, CA 92705
www.drjoelab.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr.Joe-111Dr.Joe-111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2599520menthol 1.4 % / methyl salicylate 10 % Topical OilPSN1
2599520menthol 14 MG/ML / methyl salicylate 100 MG/ML Topical OilSCD1
2599520menthol 1.4 % / methyl salicylate 10 % Topical OilSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82331-111-042024-01-30C16284748780-11030e365-5f3e-111a-e063-dadaa90a10e2DR JOE LAB PMS Menstrual Pain Relief Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82331-111-04DR JOE LAB PMS Menstrual Pain Relief Oil1 in 1 CARTONOIL11
82331-111-04DR JOE LAB PMS Menstrual Pain Relief Oil118 mL in 1 BOTTLEOIL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82331-111DR JOE LAB PMS MENSTRUAL PAIN RELIEF OIL (MENTHOL, METHYL SALICYLATE) OIL [DR JOE LAB, INC.]1Legacy NDC, 2 package rows20220422_fee745b6-037f-40f5-9953-63eb7ca888c1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82331-11182331-111-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
EUCALYPTUS OIL2R04ONI662IACT

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
afffc92a-d8bb-4a03-859d-2e6f3b27f745fee745b6-037f-40f5-9953-63eb7ca888c12022-04-07WarningsExact identifier
spl id: afffc92a-d8bb-4a03-859d-2e6f3b27f745
spl set id: fee745b6-037f-40f5-9953-63eb7ca888c1

Reported adverse events (FAERS/openFDA)#

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