Label: HAV EZ PENETRATING PAIN RELIEF- menthol gel

  • NDC Code(s): 84093-442-00
  • Packager: PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • Drug Facts

  • Active Ingredients

    Menthol 3.00 %

    Purpose

    Topical Analgesic

  • Uses:

    Temporary relief of minor aches and pains of muscles and joints, associated with • arthritis simple backache • strains • bruises • sprains.

  • Warning:

    For external use only

    Do not use:

    On damaged or broken skin

    When using this product

    • Avoid contact with the eyes.
    • Do not bandage tightly.

    Stop use and ask a doctor if

    • Rash or irritation develops and lasts
    • Condition worsens, or if symptoms persist for more than 7 days or 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.

    IF PREGNANT OR BREAST FEEDING

    ask a health professional before use

  • Directions:

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: consult a doctor.
  • Other information:

    • Protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Carterii (Frankincense) Oil, Cannabis Saliva (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Cinnamomum Cassia Leaf Oil, Curcuma Longa (Turmeric) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Magnesium Sulfate, Olea Europaea (Olive) Oil, Phenoxyethanol, Piper Nigrum (Black Pepper) Extract, Polysorbate-20, Propylene Glycol, Triethanolamine

  • QUESTIONS

    954-747-1221

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HAV EZ PENETRATING PAIN RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84093-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    HEMP (UNII: TD1MUT01Q7)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)  
    TURMERIC (UNII: 856YO1Z64F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    GREEN OLIVE (UNII: 6HD2W46UEG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BLACK PEPPER (UNII: KM66971LVF)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84093-442-0060 mL in 1 JAR; Type 0: Not a Combination Product01/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/02/2024
    Labeler - PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC (013747732)
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