XJOW PAIN GEL

Manufacturer
Omom Pharmaceuticals, Inc.
Effective date
2017-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:39

Label at a glance#

ProductXJOW
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Storage and handling

Other information: Store in a cool dry place with lid closed tightly.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 1.25%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Reliever

INDICATIONS & USAGE SECTION

Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • simple backache • bruises • cramps • muscle strains and sprains.

WARNINGS SECTION

Warnings: For external use only.

When using this product:  • Use only as directed.  • Do not bandage tightly or use with heating pad  • Avoid contact with the eyes or mucous membranes  • Do not apply to wounds or damaged skin  • Do not use with other ointments, creams, sprays or liniments  • Do not apply to irritated skin or if excessive irritation develops  • Wash hands after use with cool water.

Stop use and ask a doctor if: • Condition worsens, or symptoms persist for more than 7 days, or clear up and reoccur within few days. • Redness is present • Irritation develops

If pregnant or breastfeeding: Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children: • If accidentally ingested, get medial help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 12 years of age and older: • Apply to the affected area. • Massage the dispensed gel, into the affected area until thoroughly absorbed. • Use as necessary. • Do not exceed 4 times a day. Children under 12 years of age: Consult physician

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Acanthopanax Senticosus Root Extract, Amber Powder, Angelica Archangelica Root Oil, Carbomer, Carthamus Tinctorius Seed Oil, Cinnamomum Cassia Leaf Oil, Cnidium Officinale Root Extract, Commiphora Myrrha Resin, Corydalis Turtschaninovii Root Extract, Curcuma Longa Root Extract, Daeonnrops Draco Extract, Dipsacus Sylvestris Extract, Dryneria, Ethyl Alcohol, Ethylhexylglycerin, Eucommia Ulmoides Leaf Extract, Gardenia Florida Oil, Ledebouriella Divaricata Root Extract, Olibanum, Orchis Mascula Flower Extract, Paeonia Officinalis Callus Extract, Panax Notoginseng Root Extract, Phenoxyethanol, Prunus Persica Kernel Oil, Rheum Palmatum Root / Stalk Extract, Triethanolamine, Water (Aqua)

STORAGE AND HANDLING SECTION

Other information: Store in a cool dry place with lid closed tightly.

SPL UNCLASSIFIED SECTION

FAST AND SUSTAINABLE RELIEF

FOR JOINT AND MUSCLE INJURIES

Naturally the right choice

Distributed by Herb-X Solutions, Inc.

3838 West Burbank Blvd. Burbank CA 91505

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XJowXJow

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866128menthol 1.25 % Topical GelPSN2
866128menthol 0.0125 MG/MG Topical GelSCD2
866128menthol 1.25 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850547005026GTIN-13: 0850547005026
EAN-13: 0850547005026
GTIN-12: 850547005026
UPC-A: 850547005026
GTIN storage (14 digits): 00850547005026
XJOW-GEL.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69934-001-042020-01-31C16284748780-19d75b9d0-f4fc-f424-e053-dadaa90a57ceXJOW PAIN GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69934-001-04XJOW113 g in 1 BOTTLE, PLASTICGEL1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69934-001XJOW (MENTHOL) GEL [OMOM PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20170130_32a46ac0-bfef-4ba6-b353-722b070b3d63.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69934-00169934-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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
4af0fa10-d5d8-472a-bbab-14e81f731c1232a46ac0-bfef-4ba6-b353-722b070b3d632017-01-30WarningsExact identifier
spl id: 4af0fa10-d5d8-472a-bbab-14e81f731c12
spl set id: 32a46ac0-bfef-4ba6-b353-722b070b3d63

Reported adverse events (FAERS/openFDA)#

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