Label: PAIN RELIEF CREAM- menthol 1.75% cream

  • 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 ingredient

    Menthol 1.75%

  • Purpose

    Menthol 1.75%........Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muslces 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), coco-caprylate, jojoba (simmondsia chinensis) esters, peppermint (mentha piperita) leaf oil, MSM (methylsulfonylmethane), cetearyl olivate, cetearyl alcohol, glycerin, organic hemp (cannabis sativa) aerial part extract, organic hemp

    (cannabis sativa) seed oil, sorbitan olivate, organic aloe (aloe barbadensis) leaf juice, ethylhexylglycerin, glucose, cetearyl glucoside, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, dehydroxanthan gum, lactoperoxidase, glucose oxidase,
    magnesium sulfate


  • Questions or comments?

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

  • Principal Display Panel

    HempFusion

    Pain

    Relief

    CREAM

    Menthol 1.75%

    Including hemp extarct with naturally occuring CBD (60mg/bottle) + Terpenes (55mg/bottle) from black pepper and clove & other natural skin moisturizers.

    U.S. HEMP AUTHORITY H CERTIFIED

    NON-GMO

    ALL SKIN TYPES

    50mL (1.69 fl oz)

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    menthol 1.75% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-987
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL17.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ALOE (UNII: V5VD430YW9)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CLOVE OIL (UNII: 578389D6D0)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HEMP (UNII: TD1MUT01Q7)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    MYELOPEROXIDASE (UNII: JQZ6YM58U5)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73672-987-501 in 1 CARTON02/10/2020
    150 mL in 1 TUBE; 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(73672-987)
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