XJOW- menthol gel 
Omom Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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XJOW PAIN GEL

Drug Facts

Active Ingredients

Menthol USP 1.25%

Purpose

Cooling Pain Reliever

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: 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.

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

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 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)

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

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

XJow

XJOW 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69934-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ELEUTHERO (UNII: ZQH6VH092Z)  
AMBER (UNII: 70J9Z0J26P)  
ANGELICA ROOT OIL (UNII: B25G881UOX)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)  
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
MYRRH (UNII: JC71GJ1F3L)  
CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z)  
TURMERIC (UNII: 856YO1Z64F)  
DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU)  
DIPSACUS FULLONUM ROOT (UNII: 4TJV827BQT)  
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCOMMIA ULMOIDES LEAF (UNII: AM272O881C)  
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)  
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P)  
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69934-001-04113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2017
Labeler - Omom Pharmaceuticals, Inc. (079869885)

Revised: 1/2017
Document Id: 4af0fa10-d5d8-472a-bbab-14e81f731c12
Set id: 32a46ac0-bfef-4ba6-b353-722b070b3d63
Version: 2
Effective Time: 20170130
 
Omom Pharmaceuticals, Inc.