EXTRA STRENGTH EEZ-AWAY (MENTHOL) LIQUID [EEZAWAY RELIEF INC]

EXTRA STRENGTH EEZ-AWAY (MENTHOL) LIQUID [EEZAWAY RELIEF INC]
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NDC 69678-131-02
Set ID 9d7fb7ea-a7f1-4c2b-8e38-ed876a72a93a
Category HUMAN OTC DRUG LABEL
Packager EEZAWAY RELIEF INC
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts

  • Active Ingredient:

    Menthol 2.50%

  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises ■ cramps

  • Warnings

    For external use only

    When using this product ■ use only as directed ■ do not bandage tightly or use with heating pad ■ avoid contact with eyes and mucous
    membranes ■ do not apply to wounds or damaged, broken or irritated skin ■ a transient burning sensation or redness may occur upon
    application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not
    expose the area treated with product to heat or direct sunlight

    Stop use and ask a doctor if ■ Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Flammable ■ keep away from fire or flame

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 12 years: ■ apply generously to affected area ■ massage into painful area until thoroughly absorbed into skin
    ■ repeat as necessary, but no more than 3 to 4 times daily
    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
    children 12 years or younger: ask a doctor

  • Inactive Ingredients

    Emu Oil, Fragrance, Glucam P-20, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate Crystal USP, Tincture of Iodine USP

  • SPL UNCLASSIFIED SECTION

    FOR TEMPORARY RELIEF OF MINOR ACHES AND PAINS ASSOCIATED WITH

    • ARTHRITIS
    • ACUTE BACKACHE
    • SORE & TIRED MUSCLES

    Recommended by

    Physicians • Professionals • Atheletic Trainers

    For Topical Use Only

    BLUE PLANT FARMS

  • Packaging

    eez-label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH EEZ-AWAY 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69678-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EMU OIL (UNII: 344821WD61)  
    PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL-10 OLEYL ETHER (UNII: JD797EF70J)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    IODINE (UNII: 9679TC07X4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69678-131-0288 mL in 1 BOTTLE; Type 0: Not a Combination Product03/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/13/2019
    Labeler - EEZAWAY RELIEF INC (079751465)

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