XJOW by Omom Pharmaceuticals, Inc. XJOW- menthol gel

XJOW by

Drug Labeling and Warnings

XJOW by is a Otc medication manufactured, distributed, or labeled by Omom Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

XJOW 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69934-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69934-001-04	113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/15/2017

Labeler - Omom Pharmaceuticals, Inc. (079869885)