Label: XJOW- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 30, 2017

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Menthol USP 1.25%

  • Purpose

    Cooling Pain Reliever

  • INDICATIONS & USAGE

    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

    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 REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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

    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

    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

    XJow

  • INGREDIENTS AND APPEARANCE
    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)