EEZ-AWAY RELIEF (MENTHOL) SPRAY [EEZAWAY RELIEF INC]

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EEZ-AWAY RELIEF (MENTHOL) SPRAY [EEZAWAY RELIEF INC]
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NDC 69678-101-04, 69678-101-06, 69678-101-08
Set ID 5eb7deb4-e7e4-4ee3-a002-b982b59fb7cf
Category HUMAN OTC DRUG LABEL
Packager EEZAWAY RELIEF INC
Generic Name
Product Class
Product Number
Application Number PART348
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  • ACTIVE INGREDIENT:

    Menthol 1.25%

  • PURPOSE

    Liquid Analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    FOR THE TEMPORARY RELIEF OF MINOR ACHES & PAINS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE & SORE, TIRED MUSCLES.

  • PRECAUTIONS

    CAUTION: Do not apply to wounds or damaged skin. If rash or irritation occurs, discontinue use.

  • WARNINGS

    The application of external heat, such as an electric heating pad, may result in excessive skin irritation or burn. Avoid contact with the eyes and mucous membranes. Do not bandage tightly. Do not inhale.

  • DIRECTIONS FOR USE

    Apply EEZ-AWAY® generously to the affected area. Let dry, then re-apply. For maximum pain relief, apply, let dry and re-apply five times daily or as needed.

  • INACTIVE INGREDIENT

    INGREDIENTS: Isopropyl Alcohol, Deionized Water (Aqua), PEG-75 Lanolin, Iodine, Oleth-10, PPG-20 Methyl Glucose Ether Distearate, Sodium Iodide, Sodium Thiosulfate, Ethyl Alcohol, Fragrance.

  • QUESTIONS

    To reorder call: 302-339-3030

  • Packaging

    eez-label

  • INGREDIENTS AND APPEARANCE
    EEZ-AWAY RELIEF 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69678-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    IODINE (UNII: 9679TC07X4)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL-10 OLEYL ETHER (UNII: JD797EF70J)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    PPG-20 METHYL GLUCOSE ETHER DISTEARATE (UNII: 0057334FAB)  
    SODIUM IODIDE (UNII: F5WR8N145C)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    Product Characteristics
    Colorbrown (amber) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69678-101-08236.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/19/2015
    2NDC:69678-101-06177.4 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/31/2017
    3NDC:69678-101-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/19/2015
    Labeler - EEZAWAY RELIEF INC (079751465)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm Inc.049121643manufacture(69678-101)
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