Label: EB302 ARTHRITIS RELIEF- menthol spray

  • 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 March 20, 2018

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 1.7307%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches & pains of muscles & joints associated with arthritis

  • Warnings

    For external use only

    Do not use

    • on ears or nasal cavity
    • if pregnant
    • on wounds or damaged skin
    • otherwise than as directed

    When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • Conditions worsen
    • Symptoms persist for more than 7 days, or symptoms clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and over

    Spray sufficient amount onto affected area to cover it completely, and rub until dry. Repeat no more than 3 times daily.

    Children under 12 years of age

    Consult a doctor.

  • Other information

    Store at cool place (room temperature) away from heat and light sources.

  • Inactive ingredients

    Alcohol, Amaranthus Viridis Leaf, Animal Fat, Gaultheria Procumbens (Wintergreen) Leaf Extract, Glycerin, Mesona Chinensis Whole, Water

  • Questions?

    Call 1-562-207-8624

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    EMINENCE BIOTECH CORPORATION LIMITED

    3411 SILVERSIDE ROAD, RODNEY BUILDING # 104
    WILMINGTON DE19810 NEW CASTLE COUNTY, USA

  • PRINCIPAL DISPLAY PANEL - 50mL Bottle Carton

    EB
    Eminence
    Biotech

    EB302

    ARTHRITIS RELIEF SPRAY

    1.69FL OZ (50mL)
    NDC 53304-03021

    PRINCIPAL DISPLAY PANEL - 50mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    EB302 ARTHRITIS RELIEF 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53304-0302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM865.4 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMARANTHUS VIRIDIS LEAF (UNII: 7T0WZ76K1T)  
    PORK SIDE BACON, CURED FAT (UNII: 6E710H379S)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PLATOSTOMA PALUSTRE WHOLE (UNII: FE70D062O9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53304-0302-11 in 1 BOX11/01/2012
    150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34811/01/2012
    Labeler - EMINENCE BIOTECH CORPORATION LIMITED (078531141)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!