Label: PAIN RELIEF GEL- menthol 1.5% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 17, 2021

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  • Active Ingredients

    Menthol 1.5%

  • Purpose

    Menthol 1.5%........Topical Analgesic

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes
    • do not bandage tightly
    • do not apply to wounds or damaged skin

    Stop use and ask doctor if

    • condition worsens
    • irritation occurs
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding, 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 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: consult a doctor.

  • Other information

    • Store in a cool dry place away from light
  • Inactive ingredients

    water (aqua), glycerin, peppermint (mentha piperita) leaf oil, coco-caprylate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, organic aloe (aloe barbadensis) leaf juice, arnica (arnica montana) flower extract, pepper (capsicum annuum) fruit extract, ginger (zingiber officinale) root extract, organic turmeric (curcuma longa) root oil, organic rosemary (rosmarinus officinalis) leaf oil, black pepper (piper nigrum) fruit oil, clove (syzgium aromaticum) flower oil, jojoba (simmondsia chinensis) esters, lysolecithin, sclerotium gum, ethylhexylglycerin, glucose, pullulan, xanthan gum, glucose oxidase, lactoperoxidase, silica, magnesium sulfate, organic eucalyptus (eucalyptus globulus) leaf oil

  • Questions or comments?

    Call 877-669-4367 Monday through Friday, 9am-5pm EST.

  • PRINCIPAL DISPLAY PANEL

    HempFusion

    Pain ReliefGel

    Menthol 1.5%

    Including moisturizing Arnica, hemp extract with naturally occuring CBD (65mg/bottle) + Terpenes (60mg/bottle) from black pepper and clove & other natural skin moisturizers

    U.S. HEMP AUTHORITY CERTIFIED

    NON-GMO

    ALL SKIN TYPES

    50mL (1.69 fl oz)

    carton

    bottle

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF GEL 
    menthol 1.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-989
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HEMP (UNII: TD1MUT01Q7)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALOE (UNII: V5VD430YW9)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CLOVE OIL (UNII: 578389D6D0)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    WATER (UNII: 059QF0KO0R)  
    CAPSICUM (UNII: 00UK7646FG)  
    GINGER (UNII: C5529G5JPQ)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    MYELOPEROXIDASE (UNII: JQZ6YM58U5)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73672-989-501 in 1 CARTON02/10/2020
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2020
    Labeler - HEMPFUSION, INC. (117152485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc. (DBA Paklab)177711082manufacture(73672-989)
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