Label: EB301AP PAIN RELIEF- menthol spray

  • Category: HUMAN OTC DRUG LABEL

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 1%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of pain

  • 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 to 4 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, Animal Fat, Euphorbia Hirta, Euphorbia Thymifolia Whole, Gaultheria Procumbens (Wintergreen) leaf Extract, Glycerin, 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 - 100 mL Bottle Carton

    EB
    Eminence
    Biotech

    EB301AP

    PAIN RELIEVING SPRAY

    3.38FL OZ (100mL)

    NDC 53304-0301-1

    Principal Display Panel - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    EB301AP PAIN RELIEF 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53304-0301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1000 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    EUPHORBIA HIRTA (UNII: L13YF113GN)  
    PORK SIDE BACON, CURED FAT (UNII: 6E710H379S)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EUPHORBIA THYMIFOLIA WHOLE (UNII: D56Y3D2OTL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53304-0301-11 in 1 BOX03/01/2013
    1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:53304-0301-31 in 1 BOX03/01/2013
    215 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 finalpart34803/01/2013
    Labeler - EMINENCE BIOTECH CORPORATION LIMITED (078531141)
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