Label: XJOW- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69934-001-04 - Packager: Omom Pharmaceuticals, Inc.
- 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
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- Drug Facts
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
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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.
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- DOSAGE & ADMINISTRATION
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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)
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INGREDIENTS AND APPEARANCE
XJOW
menthol gelProduct 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)