Label: EB301CT BRUISE PAIN RELIEF- menthol spray

  • NDC Code(s): 53304-1301-1
  • Packager: EMINENCE BIOTECH CORPORATION LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Menthol 1.70%

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  • Purpose

    Topical Analgesic

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  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with bruises

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  • 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.

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  • 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.

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  • Other information

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

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  • Inactive ingredients

    Alcohol, Amaranthus Viridus Leaf, Animal Fat, Euphorbia Thymifolia Whole, Gaultheria Procumbens (Wintergreen) leaf Extract, Glycerin, Water

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  • Questions?

    Call 1-562-207-8624

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    EMINENCE BIOTECH CORPORATION LIMITED

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

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  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    EB
    Eminence
    Biotech

    EB301CT

    Pain Relieving Spray for Bruises

    3.38FL OZ (100mL)

    NDC 53304-1301-1

    Principal Display Panel - 100 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    EB301CT BRUISE PAIN RELIEF 
    menthol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53304-1301
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 1700 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    AMARANTHUS VIRIDIS LEAF  
    PORK SIDE BACON, CURED FAT  
    GAULTHERIA PROCUMBENS LEAF  
    GLYCERIN  
    EUPHORBIA THYMIFOLIA WHOLE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53304-1301-1 1 in 1 BOX
    1 100 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 03/01/2013
    Labeler - EMINENCE BIOTECH CORPORATION LIMITED (078531141)
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