EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]

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  • EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]

EB301AP PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]
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NDC 53304-0301-1, 53304-0301-3
Set ID 3a5fe77f-c36a-41c0-ba86-0664b942e144
Category HUMAN OTC DRUG LABEL
Packager EMINENCE BIOTECH CORPORATION LIMITED
Generic Name
Product Class
Product Number
Application Number PART348
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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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